[Senate Hearing 112-797]
[From the U.S. Government Printing Office]
S. Hrg. 112-797
A NATION PREPARED: STRENGTHENING MEDICAL AND PUBLIC PREPAREDNESS AND
RESPONSE
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED TWELFTH CONGRESS
FIRST SESSION
ON
EXAMINING STRENGTHENING MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND
RESPONSE
__________
MAY 17, 2011
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
TOM HARKIN, Iowa, Chairman
BARBARA A. MIKULSKI, Maryland MICHAEL B. ENZI, Wyoming
JEFF BINGAMAN, New Mexico LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington RICHARD BURR, North Carolina
BERNARD SANDERS (I), Vermont JOHNNY ISAKSON, Georgia
ROBERT P. CASEY, JR., Pennsylvania RAND PAUL, Kentucky
KAY R. HAGAN, North Carolina ORRIN G. HATCH, Utah
JEFF MERKLEY, Oregon JOHN McCAIN, Arizona
AL FRANKEN, Minnesota PAT ROBERTS, Kansas
MICHAEL F. BENNET, Colorado LISA MURKOWSKI, Alaska
SHELDON WHITEHOUSE, Rhode Island MARK KIRK, Illinois
RICHARD BLUMENTHAL, Connecticut
Daniel E. Smith, Staff Director
Pamela Smith, Deputy Staff Director
Frank Macchiarola, Republican Staff Director and Chief Counsel
(ii)
C O N T E N T S
__________
STATEMENTS
TUESDAY, MAY 17, 2011
Page
Committee Members
Harkin, Hon. Tom, Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 1
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina....................................................... 2
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania, prepared statement............................... 4
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming,
prepared statement............................................. 5
Blumenthal, Hon. Richard, a U.S. Senator from the State of
Connecticut.................................................... 14
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas....... 18
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 22
Witness--Panel I
Lurie, Nicole, M.D., M.S.P.H., Assistant Secretary for
Preparedness and Response, U.S. Department of Health and Human
Services, Washington, DC....................................... 7
Prepared statement........................................... 9
Witnesses--Panel II
Kadlec, Robert P., M.D., MTH&H, MA, Vice President, Global Public
Sector, PTRM Management Consultants, Washington, DC............ 25
Prepared statement........................................... 27
Arthur, Phyllis, Senior Director, Vaccines, Immunotherapeutics
and Diagnostics Policy, Biotechnology Industry Organization,
Washington, DC................................................. 31
Prepared statement........................................... 33
Anderson, Michael R., M.D., FAAP, Vice President and Associate
Chief Medical Officer at University Hospitals and Associate
Professor of Pediatric Critical Care at Rainbow Babies &
Children's Hospital, Cleveland, OH............................. 38
Prepared statement........................................... 40
Cooper, Susan R., MSN, RN, Commissioner, Tennessee Department of
Health, Nashville, TN.......................................... 47
Prepared statement........................................... 49
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Senator Barbara A. Mikulski.................................. 62
Senator Kay R. Hagan......................................... 63
Governor, Lowell P. Weicker, President of the Board of
Directors, Trust for America's Health...................... 64
(iii)
A NATION PREPARED: STRENGTHENING
MEDICAL AND PUBLIC PREPAREDNESS AND RESPONSE
----------
TUESDAY, MAY 17, 2011
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 2:37 p.m. in Room
430, Dirksen Office Building, Hon. Tom Harkin, Chairman of the
committee, presiding.
Present: Senators Harkin, Enzi, Casey, Whitehouse,
Blumenthal, Burr, Hatch, and Roberts.
Opening Statement of Senator Harkin
The Chairman. The committee on Health, Education, Labor,
and Pensions will come to order.
I am pleased to convene this hearing today on a very
important issue, defending our Nation against public health
threats. Such threats are diverse in origin and include
exposure to chemical, biological, radiological or nuclear
agents. Sometimes these threats occur naturally, the 2009 H1N1
pandemic influenza, for example, or they can be the result of
malicious intent, such as the intentional release of the
anthrax in 2001. A recent and very challenging example is the
radiation leak that occurred at the nuclear plant damaged in
Japan's massive earthquake.
It is not just known threats that place the health and
well-being of Americans at risk, there are just as many
emerging or unknown threats against which protection is
critical. Because the impact of these threats could be
catastrophic, it is imperative we continue to strengthen the
Nation's ability to adequately prepare for and appropriately
respond to a public health emergency. Building our Nation's
response capacity requires close collaboration among Federal,
State and local governments, hospitals and healthcare
providers, businesses, schools, and indeed all Americans.
I have long taken very seriously the Federal Government's
role in being prepared for a public health emergency, public
health preparedness, as it is called. We have made tremendous
progress in preparedness during the last decade. One important
aspect of public health preparedness is the advanced
development and procurement of medical countermeasures. These
are the vaccines, therapies and diagnostics needed to prevent
or respond to a bioterrorism event or other public health
emergency.
In an effort to ensure that we have the appropriate medical
countermeasures, we need to continue to support innovative
research into promising new products and ensure that products
are readily available during a time of emergency. We also need
to address the scientific challenges of identifying safe and
effective medical countermeasures when human trials are not
available or ethical. Such scientific challenges pose
regulatory issues that we will hear more about from our
distinguished panel of witnesses today.
Underlying all of our preparedness activities is the issue
of how to ensure that our most vulnerable citizens will be
protected should disaster strike. We know that many
populations, including individuals with disabilities, seniors
and children may have unique needs that we have the
responsibility to address during a public health emergency.
This came to the forefront during Hurricane Katrina and people
with disabilities. In the past, when faced with catastrophic
events, we have too often seen such needs go unmet.
The purpose of this hearing is to learn more about the
significant progress our Nation has made in preparing for and
responding to public health threats and challenges and the
barriers that may exist. It is even more important to discuss
ways in which we can use lessons learned to create a stronger
and more prepared Nation.
So I look forward to hearing suggestions from our witnesses
on ways to strengthen our public health preparedness as this
committee begins its work on reauthorizing the Pandemic and
All-Hazards Preparedness Act, known as PAHPA, hopefully during
this congressional session.
I yield to Senator Enzi for an opening statement.
Senator Enzi. Mr. Chairman, I am going to yield to Senator
Burr for a statement. If you have two on your side, then I will
have one as well. If you don't, I will put mine in the record.
But I need to have Senator Burr do an opening statement because
in 2006 he was the lead----
The Chairman. That is right.
Senator Enzi [continuing]. On doing this particular bill
and I sat with him in a number of negotiation sessions with
Senator Kennedy and Senator Dodd, as they worked out all of the
issues that we were aware of at that time. And he did just a
masterful job and really understands this bill and was really
in charge of it and it is largely thanks to him that we were
able to get it done.
And of course we were worried about bird flu at that time
and we had the measures in place. So I would yield to Senator
Burr.
Statement of Senator Burr
Senator Burr. Mr. Chairman, thank you. And Senator Enzi,
thank you for yielding to me for an opening statement. I
welcome our entire panels, especially Dr. Lurie for being here.
Mr. Chairman, one of the committee's greatest
responsibilities is ensuring that our Nation has the medical
and public health preparedness and response capabilities
necessary to respond to all hazards and all threats, whether
natural or manmade. The Pandemic and All Hazard Preparedness
Act answered the critical question of who is in charge through
the creation of the Assistant Secretary for Preparedness and
Response. This law strengthened our medical surge capabilities
and improved State and local public health security. PAHPA also
enhanced medical countermeasure research, development and
procurement through the creation of the Biomedical Advanced
Research and Development Authority.
As we work to reauthorize the Pandemic and All Hazards
Preparedness Act and BioShield, it is critical that this
committee take a hard look at what is working well and what is
not working well. The good news is that we have come a long
way, and as H1N1 demonstrated, we are better prepared to
respond to the public health emergencies today than we were 5
years ago. But while we have come a long way, we know that much
work remains to be done, and we cannot lose sight of the
urgency surrounding our work in this area.
Just today, news broke that the department plans to make
cuts to preparedness programs. This raises significant
questions as to how the administration is prioritizing and
coordinating their preparedness and response mission. Medical
and public health preparedness and response is a matter of
national security. PAHPA's reauthorization is the opportunity
to make the targeted and strategic changes to the medical and
public health preparedness and response authorities and
programs necessary to strengthen and improve our capabilities
to successfully respond to all threats.
We have the opportunity to draw upon the lessons learned
after 5 years, the 2009 H1N1 influenza pandemic, the Haiti
disaster, the Gulf oil spill and the recent disaster in Japan.
Many of these incidents underscore the ability of Mother Nature
to throw us a biological curve ball with the potential to wreak
havoc on the scale of the 1918 pandemic. The death of Osama bin
Laden is a sobering reminder that the 21st century threats are
real and we must be prepared to address chemical, biological,
radiological and nuclear threats.
The Commission on the Prevention of WMD Proliferation and
Terrorism has repeatedly warned that it is,
``more likely than not, that a weapon of mass
destruction will be used in a terrorist act by the end
of 2013 and that we must make bioterrorism a higher
priority.''
Just last year the WMD Commission again warned that we are,
``woefully behind in our capability to rapidly produce vaccines
and therapeutics,'' which we all know is critical for
responding to CBRN threats, whether natural or manmade.
Last year the administration's Public Health Emergency
Medical Countermeasures Enterprise review concluded,
`Our Nation must have the nimble, flexible capability
to produce medical countermeasures rapidly in the face
of an attack or threat, known or unknown, including a
novel, previously unrecognized, naturally occurring
emerging infectious disease.''
If we are to achieve the shared goal of having a prepared
Nation capable of responding to all hazards and all threats, we
must ensure the continuity of critical medical preparedness and
public health preparedness authorities and programs. We must
ensure that these programs are targeted, sound in achieving the
measured results and returns American taxpayers expect and
deserve.
Where we have not gotten the policy exactly right, we must
take this opportunity to refocus, to strengthen and to improve
these programs and authorities. This includes ensuring that our
medical countermeasures public/private partnerships reflect
modern day threats and the Food and Drug Administration
provides the regulatory certainty and support to ensure a
robust medical countermeasure enterprise. We must foster and
accelerate the development and innovation of medical
countermeasures, which includes fully funding BARDA's advanced
research and development. Let me restate that, which requires
fully funding BARDA's advanced research and development
funding.
We have always been able to come together in a bipartisan
manner on this issue when it comes to prioritizing medical and
public health preparedness and response. Our work in this area
is a matter of national security.
And to the Chairman and the Ranking Member I look forward
to again partnering with my colleagues to reauthorize PAHPA and
BioShield and to do it in this Congress. I thank the Chair.
The Chairman. Thank you, Senator Burr and thank you also
for your great leadership on this whole issue, as Senator Enzi
said, going back several years when you led the effort in this
committee. Thank you for that leadership very much.
And Senator Casey, also, I guess the two of you are co-
sponsoring the reauthorization bill this year. I would
recognize Senator Casey for an opening statement--if you want.
Statement of Senator Casey
Senator Casey. I will submit a statement for the record.
Thank you, Mr. Chairman.
[The prepared statement of Senator Casey follows:]
Prepared Statement of Senator Casey
I'd like to thank my distinguished colleagues, Senator
Harkin, Senator Enzi and Senator Burr, for their efforts to
ensure that our Nation is prepared for a medical emergency. I
am honored to be working with you on a bipartisan
reauthorization of the Pandemic All Hazards Preparedness Act.
I'd also like to recognize our distinguished panelists here
today--Dr. Lurie it is good to see you again--and thank you for
your tireless work on protecting Americans from public health
threats.
Few issues are as central to the role of the Federal
Government as protecting its citizens from a public health
emergency--be it natural or manmade.
Recent disasters from the past few years--the earthquake in
Haiti and in Japan, and the H1N1 outbreak closer to home--have
illuminated both the strengths and weaknesses of our
preparedness and response capabilities.
In light of the recent capture of Osama Bin Laden, many
have suggested that the United States needs to be even more
vigilant about a possible terrorist attack.
I, like many Americans, am concerned about what progress we
have made in the past few years since the Pandemic All Hazards
Preparedness Act was passed in developing and licensing
medicines that will help inoculate and cure the greatest health
threats we face.
Since 2004, the Department of Homeland Security has
determined that 13 chemical, biological, radiological, and
nuclear agents pose a high consequence in terms of people
exposed to the pathogens. These are anthrax, glanders,
melioidiosis, botulism toxin, Ebola virus, tularemia, a variety
of hemorrhagic fevers, typhus, smallpox, plague, and
radiological and nuclear materials.
Through my work with Senator Burr on the Weapons of Mass
Destruction Caucus, I know all too well how real these threats
are and what a catastrophic disaster such an attack would
impose.
I know, too, that we have made progress in some of these
areas when it comes to developing medical countermeasures. But
I am concerned about reports that progress is coming along very
slowly--and that we do not have the right level of scientific
knowledge and resources devoted to this priority.
I look forward to hearing your testimony today and
discussing what else we, in Congress, can do to support the
public health preparedness and response enterprise.
The Chairman. I appreciate that very much, Senator Casey.
Senator Enzi.
Statement of Senator Enzi
Senator Enzi. Mr. Chairman, I'll submit mine to the record.
And I will turn over the Ranking Member duties to Senator Burr.
I have to be at another meeting.
I do want to thank Senators Hatch and Roberts for their
work on this issue as well, before, and the leadership they
provided and the fact that they're here to participate today,
too.
[The prepared statement of Senator Enzi follows:]
Prepared Statement of Senator Enzi
Good afternoon. From the start, I would like to thank the
Chairman for holding this hearing and for his attention to
public health and medical preparedness and response. I would
also like to thank Assistant Secretary Lurie and the
distinguished panel of witnesses who made time in their busy
schedules to appear here today to discuss these matters
critical to our national security. Thank you for your time in
appearing before the committee and I look forward to your
testimony.
In 2006, our Nation took a critical step in shoring up the
national security and safety of all citizens when Congress
passed the Pandemic and All-Hazards Preparedness Act. I want to
thank Senator Burr for his continued leadership on this
critically important issue. I would also like to thank my
colleagues on both sides of the aisle; this issue enjoys broad
bipartisan support and leadership from many members.
We have made tremendous progress in the past 5 years to
ensure that we are prepared to meet all known and unknown
hazards that threaten our citizens. At the same time, there are
still gaps in the system that need to be filled and threats yet
to be addressed. We have seen first-hand the critical need for
a robust and active public health system that is able to
anticipate and respond to threats quickly and effectively. We
experienced the H1N1 pandemic that tested our Nation's ability
to meet the public health needs of our citizens, learned from
the public health emergency response in Haiti, and more
recently, took action in helping to mitigate the nuclear crisis
in Japan. We need to take these experiences and incorporate the
lessons learned as we continue to strengthen our preparedness
and improve our response capabilities.
One of the areas we can always improve on is coordination
and accountability. Along each step of the process it is
essential to ensure that Federal, State and local entities are
working in concert with each other. It is critical that roles
and responsibilities are well-defined so that there is no
uncertainty in a time of crisis and so attention can be focused
on the threat at hand. One thing that we can be certain of is
that our enemies will be coordinated in any attack against us;
therefore we need a clear strategy for preventing and
responding to such potential threats.
PAHPA invested in the development, production, and
procurement of medical countermeasures to ensure we are
prepared to address any potential chemical, biological,
radiological, or nuclear threats, particularly against those
who would do us harm. It is important that we continue the
momentum achieved by the creation of BARDA and BioShield. This
is one area in which I particularly look forward to hearing
from the witnesses about the successes and challenges for
future countermeasure development.
As always with government programs, I strongly emphasize
and encourage responsible use of Federal funding. When it comes
to national public health preparedness programs, we have the
important responsibility to be careful stewards of Federal
funds and at the same time strengthen our safety systems.
Building in more metrics to improve accountability across the
full public health emergency enterprise helps encourage
enhanced fiscal management and better outcomes.
While the Federal Government plays a critical role, it is
truly the dedicated professionals at the State and local level
who respond to public health emergencies. State and local
governments have risen to the challenges of the past 5 years,
and the people who serve in all levels of government know
first-hand the challenges of preparing and responding to public
health threats. I am proud of their work and applaud their
often unseen efforts to make sure every citizen is safe in the
event of a public health crisis.
The very real threats facing our Nation are serious and
sobering. I am, however, confident in the enterprising spirit
of Americans and our ability to protect our country. Faced with
the realities of the world we live in, we need to harness our
abilities to think beyond the expected threats and prepare for
those we don't know.
Thank you, Chairman Harkin. I look forward to hearing from
this excellent panel of witnesses.
The Chairman. Thank you very much, Senator Enzi. Now I have
the privilege of introducing Dr. Nicole Lurie and then I am
going to turn the chair over to Senator Casey.
So, I would like to welcome Dr. Nicole Lurie, the Assistant
Secretary for Preparedness and Response at the Department of
Health and Human Services.
Dr. Lurie comes to us today with significant experience in
the field of public health and preparedness. For the last
several years she has worked with HHS, the Department of
Veterans Affairs and State and local health departments on H1N1
preparedness. Prior to joining HHS, Dr. Lurie directed the RAND
Corporation's Center for Population Health and Health
Disparities and served as co-
director of RAND's Center for Domestic and International
Health.
We thank you, Dr. Lurie, for joining us today and sharing
your expertise with the committee.
That will be our first panel. And then we will go to our
second panel after that. And Dr. Lurie, your statement will be
made a part of the record in its entirety.
I am going to turn the chair over to Senator Casey at this
time. But please proceed, as you so desire.
STATEMENT OF NICOLE LURIE, M.D., M.S.P.H., ASSISTANT SECRETARY
FOR PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES, WASHINGTON, DC.
Dr. Lurie. Thank you, Chairman Harkin, Ranking Member Enzi
and distinguished members of the committee and especially the
papa of PAHPA here, Mr. Burr.
Recent events serve to remind us----
[Laughter.]
Dr. Lurie [continuing]. Of the significant challenges that
we face from an ever present terrorist threat to unprecedented
weather events and how quickly and unpredictably the call to
support the American people can arise. Since joining ASPR
almost 2 years ago I've had the privilege to share with you
some of our accomplishments, many of which were made possible
by the authorities provided in PAHPA and were a direct result
of coordinated and collaborative efforts across HHS. In fact,
every aspect of HHS has been involved with our office during
responses over the past 2 years.
H1N1 tested our ability to adapt and respond to a novel
influenza stream. The experience highlighted the
interdependence of public health, the healthcare system and
community and business organizations. It confirmed that
emergencies, particularly large ones that tax an entire health
and public healthcare system, requires us to innovate. One
result is that we are looking at how we can be more flexible in
getting the right resources, whether countermeasures or
healthcare professionals, to where they are needed in an
emergency, and at the right time.
Both H1N1 and the Japanese nuclear situation demonstrated
the importance of deploying medical countermeasures as quickly
as possible after an incident. We are advancing efforts to
strengthen the development of new and promising countermeasures
and to ensure that safe, effective countermeasures can be
quickly delivered to populations in need. Our efforts in this
area are aligned through the Public Health Emergency
Countermeasures Enterprise, or PHEMCE, an interagency body that
defines and prioritizes medical countermeasures requirements,
research, investments and procurements. The Secretary's
Countermeasures Enterprise Review included recommendations to
strengthen and improve this enterprise so that we get the
products we need to manage an unprecedented health emergency.
One critical demonstration of the U.S. Government's
commitment to ensuring we have the tools to treat the affects
of these agents is the BioShield Program. Since its inception
we have successfully procured products for the Strategic
National Stockpile to treat the affects of anthrax, botulism,
smallpox and products for radiologic and nuclear events.
As you may have heard, just last week we announced a major
BioShield contract for a smallpox antiviral. This award is a
prime example of how the system is supposed to work. Taking a
product without a viable commercial market from early research
through advanced development under BARDA, to procurement,
significantly strengthening our ability to protect the United
States from a bio threat.
The Haiti earthquake demonstrated the readiness of our
country to extend extraordinary humanitarian assistance and
taught us valuable lessons that we are now acting on. For
example, we are strengthening how we do domestic operations
within the National Disaster Medical System to best serve
stakeholders and are approving methods for collecting health
data through the NDMS electronic medical record to better
identify specific populations needs to ensure that we have a
nimble and flexible NDMS response that is right-sized and
focused on the right need.
As we work to address the needs of at-risk population, we
join FEMA in adopting a whole community approach to our
planning. We have taken steps to ensure that at-risk
individuals, children, pregnant women, seniors and other
individuals who have specific needs, are included at every step
of our planning for medical countermeasures. The whole
community approach leads us to focus on the local level,
including State and local government and private sector
partners in strengthening preparedness efforts and in being
innovative in how we do so.
PAHPA authorized two cooperative agreement programs that
have been critical to ensuring that State and local
jurisdictions have the resources to prepare for public health
incidents, the Hospital Preparedness Program and the Public
Health Preparedness Cooperative Agreements. And while these
programs aim to strengthen different parts of the system, they
share common objectives. A key priority for me is the alignment
of these programs to ensure efficient use of limited resources
and eliminate duplicative or conflicting programmatic guidance
and reducing the programmatic burden for grantees.
State and local jurisdictions rely on these programs to
enhance preparedness and response and there are now numerous
examples of States being able to handle events without Federal
augmentation. A few weeks ago I visited areas of the south
impacted on by the recent tornados and I heard firsthand how
important these programs were to effective response. These and
other experiences have confirmed the critical importance of a
single point of contact for coordinating preparedness and
response envisioned by PAHPA.
The experience, since its passage, has shown clearly that
every part of the public health and medical community is
critical to making our Nation and our communities more
resilient. And the national health security strategy, that you
envisioned, charts our way forward.
We applaud Congress' wisdom in enacting PAHPA as the
foundation for this approach and I look forward to working with
all of you as PAHPA is reauthorized in this Congress. I would
be happy to take any questions that you might have.
[The prepared statement of Dr. Lurie follows:]
Prepared Statement of Nicole Lurie, M.D., M.S.P.H.
Good afternoon Chairman Harkin, Ranking Member Enzi, and
distinguished members of the committee. I am pleased to be here today
on behalf of the U.S. Department of Health and Human Services (HHS) to
testify on national public health preparedness and response. My name is
Nicole Lurie and I serve as the HHS Assistant Secretary for
Preparedness and Response. Today, I will discuss how critically
important the Pandemic and All Hazards Preparedness Act (PAHPA; the
Act) is to our public health preparedness and the progress we have made
since its enactment in 2006.
First, I would like to recognize the Congress, and especially this
committee, for its strong leadership in advancing the public health and
preparedness of our Nation by enacting this important legislation in
2006. PAHPA has supported our efforts to foster stronger, more
resilient communities able to respond to and recover from public health
emergencies. PAHPA established the foundation for a consolidated and
thorough response to emergencies and HHS has since built on these
authorities to ensure the Nation has the tools necessary to save lives.
the pandemic and all-hazards preparedness act established a formalized
approach to public health preparedness
PAHPA strengthened our country's foundation for public health
preparedness by helping us fix some of the problems our Nation
encountered when preparing for and responding to disasters in the past.
As we have seen from a variety of recent emergencies and disasters as
of late--including tornados, floods, influenza pandemic, earthquakes,
damage to a nuclear facility and a large oil spill--there is always a
significant impact to the public's medical care and public health.
The Pandemic and All-Hazards Preparedness Act has been instrumental
to support State and local preparedness and response efforts. Since the
passage of the Act, HHS has implemented a number of initiatives to
strengthen preparedness and response efforts. We look forward to
working with you on improvements to strengthen our public health and
medical preparedness and response.
The Pandemic and All-Hazards Preparedness Act designated the HHS
Secretary as the lead Federal official for public health and medical
response to emergencies and incidents covered by the National Response
Plan and its successor plans, and created my office, the Office of the
Assistant Secretary for Preparedness and Response (ASPR). Under the
Act, ASPR serves as the principal advisor to the Secretary on all
matters related to Federal public health and medical preparedness and
response and plays a pivotal role in coordinating emergency response
efforts across the various HHS agencies and among our Federal
interagency partners.
Guided by the authorities in PAHPA, HHS established organizational
priorities and enhanced its operations and response capabilities.
Moreover, to carry out PAHPA authorities, ASPR's mission was defined as
leading the country in preparing for, responding to, and recovering
from health effects of emergencies and disasters by supporting our
communities' abilities to withstand adversity, strengthening our health
and response systems, and enhancing national health security. The
future of Federal public health and medical preparedness and response
is a ``whole community'' approach. This approach requires that we
institutionalize community resilience by building practices nationally
that strengthen preparedness efforts implemented by local institutions
including State and local government and private sector partners;
creating a fundamental body of knowledge for preparedness, response,
and recovery; and encouraging innovative efforts to build the Nation's
capacity to stabilize and recover from an event. We are also working to
ensure that our public and private sector partners are promoting a
culture of budget preparedness to quickly and efficiently get resources
where they are needed before and after a disaster.
the national health security strategy established a common strategic
framework to align national preparedness efforts
Since the enactment of PAHPA in 2006, HHS has had many significant
accomplishments preparing for and responding to public health
incidents. To help better align efforts internally, support and promote
coordination efforts with Federal, State, local, and private sector
partners, and be efficient stewards of Federal dollars, in December
2009 we released the National Health Security Strategy (NHSS)--a
blueprint for preparedness and response. PAHPA required the completion
of a NHSS as a first step in ensuring we have a fully integrated and
coordinated strategy to address how various sectors of our medical and
public health systems will work together to respond to emergencies and
save lives.
The principle at the heart of the strategy is that our public
health security is about ensuring resilient communities; health systems
that coordinate and work together during disasters; and public and
private sectors working together. National health security is a shared
responsibility--from individuals and families, to private industry, to
every level of government. It recognizes that to build community
resilience we need effective public health systems working seamlessly
in collaboration with a strong healthcare system. The NHSS also
promotes building more resilient communities by including at-risk
populations in planning and day-to-day operations. Supporting this
strategy, HHS has taken steps to ensure that at-risk individuals--
children, pregnant women, senior citizens, individuals with
disabilities, and others who have special needs--are included in all
planning scenarios, guidance documents, plans, and will be effectively
treated in the event of a public health emergency.
Recognizing that we have learned a great deal about these strategic
planning processes in the past 4 years, we are interested in efforts
that enhance operational and long-term planning efforts while also
streamlining requirements. In support of the principles of the NHSS,
State and local jurisdictions have operational plans that describe
operations during pandemic influenza incidents. These plans--required
by PAHPA--include a framework that guides communications and logistics,
and coordinates general response efforts during pandemic influenza
incidents. At the time PAHPA was enacted, these plans were a relatively
new concept--the original provision was to ensure that any plan in
place was strong and relevant. To ensure the Nation is prepared for
threats beyond pandemic influenza, we believe these plans should
include planning for all-hazards.
the medical countermeasure review established the strategic and
operational plan for hhs countermeasure preparedness
To ensure the Nation has adequate countermeasures available to
respond quickly and efficiently following a chemical, biological,
radiological, nuclear (CBRN), or other public health emergency, HHS
released the Public Health Emergency Medical Countermeasures Enterprise
Review (MCM Review) in August 2010. The MCM Review identifies
``processes, policies, and activities required to take a product
concept derived from a national requirement through research, early and
advanced development, manufacturing, regulatory approval, procurement,
and stockpiling.'' This ground-breaking review looked across the entire
spectrum of product development, from early discovery through
regulatory approval, and identified the choke points where product
development was stalling or failing. To address these choke points,
which create technical, business, and regulatory risks for small
innovator companies and form the basis of the medical countermeasure
``valley of death,'' the MCM Review proposes:
The establishment of a Concept Acceleration Program at the
National Institutes of Health (NIH) National Institute of Allergy and
Infectious Diseases to work with partner agencies, academic researches,
biotechnology companies, and large pharmaceutical companies to identify
promising scientific discoveries and expedite their transformation into
practical, usable products;
The establishment of a nonprofit Strategic Investor firm
to spur innovation and create a viable biodefense business sector by
supporting companies that possess strategic technologies applicable to
both commercial and government needs, but which might otherwise lack
the necessary financial capital or business acumen to develop a
commercially viable, approved product;
The establishment of U.S.-based Centers for Innovation in
Advanced Development and Manufacturing; and,
An increased investment in regulatory sciences and review
capabilities at the Food and Drug Administration (FDA) focused on
pandemic influenza, chemical, biological, radiological, and nuclear
(CBRN) medical countermeasures (MCMs).
The Concept Acceleration Program (CAP) will leverage existing
intramural and extramural research programs as well as applied and
translational resources throughout the NIH, Centers for Disease Control
and Prevention (CDC), FDA, and Department of Defense (DOD) to expedite
the translation of promising concepts into candidate MCMs. We are
committed to applying $50M towards CAP activities in fiscal year 2011.
Evaluations are in progress to identify CAP biological product
candidates.
With congressional authorization, the Strategic Investor initiative
will spur innovation and provide the kinds of business and financial
services and support that venture capital firms typically provide,
while mitigating the risk that biotechnology firms face. The Strategic
Investor initiative will promote the transition of MCM development and
procurement from a ``one bug, one drug'' approach to an enterprise
capable of responding to any threat at any time. It is important to
note that the Strategic Investor is intended to work in concert with
the BioShield program, not replace it.
In March, we published a request for proposals for the Centers for
Innovation in Advanced Development, that we will create to reduce risk,
increase domestic manufacturing and surge capacity for MCM, and reduce
total life-cycle costs through flexible manufacturing. These U.S.-based
Centers are expected primarily to provide, on a routine basis, core
services to commercial partners who collaborate with HHS's Biomedical
Advanced Research and Development Authority (BARDA). These services
include advanced development and manufacturing capabilities and other
technical services needed by the developers of medical countermeasures
for MCMs to address national preparedness and response priorities and
needs. In the event of a pandemic, the Centers will also be available
to manufacture influenza vaccine and other biologics, as well as
provide training opportunities for the pharmaceutical workforce.
Finally, expanding regulatory science and review capabilities at
the FDA will strengthen and clarify the MCM regulatory process, which
will expedite MCM development and availability. Regulatory uncertainty
is a major barrier to engaging MCM developers in the MCM Enterprise.
This initiative will provide private sector partners with greater
access to regulators and greater clarity about the pathways to product
approval, which will reduce uncertainty and foster greater engagement
and program success.
Collectively, once implemented, these initiatives will help us
establish a more nimble and diversified approach in preparing for and
responding to CBRN, pandemic influenza and other public health threats.
pahpa helped spur development and procurement of medical
countermeasures
Prior to PAHPA, the Project BioShield Act of 2004 authorized the
Project BioShield program and established the Special Reserve Fund
(SRF). The Project BioShield Act provides additional and more flexible
authorities and funding to support and expedite the development and
procurement of CBRN medical countermeasures. The SRF is a secure
funding source for the procurement of critical medical countermeasures,
such as vaccines, therapeutics, and diagnostics that are close to or
have achieved licensure. The SRF, as industry partners and other non-
governmental stakeholders have continually asserted, is a market
guarantee for medical countermeasure development and clearly
demonstrates U.S. Government's commitment to the procurement of
security countermeasures. Finally, the Project BioShield Act provides
the Secretary with the authority to authorize the emergency use of
unapproved products or the unapproved use of approved products, if
certain standards are met.
Since its inception, we have drawn steadily on the use of Special
Reserve Funds and have developed and procured:
Anthrax therapeutics and vaccines;
Heptavalent botulinum antitoxin;
Smallpox vaccine for immunocompromised persons; and
A number of MCM products intended for use after
radiological or nuclear events.
PAHPA included authorities that strengthened Project BioShield and
HHS was able to leverage these authorities to promote successful
collaboration and procurement to keep the Nation safe against CBRN
threats. In order to improve the Federal coordination of government
policy, investments, and activities related to the development and
procurement of medical countermeasures for CBRN threats, in July 2006,
HHS established the Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE). ASPR leads the PHEMCE, which includes principal
representatives of CDC, FDA, and NIH. PHEMCE also includes key
interagency partners from DOD, the Department of Homeland Security
(DHS), the Department of Veterans Affairs (VA), and the Department of
Agriculture (USDA).
The overarching mission of PHEMCE is to:
Define and prioritize requirements for public health
emergency medical countermeasures;
Coordinate research, early and late stage product
development, and procurement activities addressing these requirements;
and
Set deployment and use strategies for medical
countermeasures held in the Strategic National Stockpile (SNS).
Using its Advanced Research and Development (ARD) authority, HHS
bridges the ``valley of death'' funding a gap that exists between the
early stages of product development and the procurement of medical
countermeasures under Project BioShield. Congress recognized that since
commercial markets do not exist for many of the products we are trying
to develop, robust funding for ARD is essential if we are to build and
sustain a substantial pipeline of products to diagnose and treat
illness, or prevent the effects of CBRN agents. Current priority
investment areas include anthrax vaccines and treatments, broad
spectrum antimicrobial drugs, and treatments and diagnostics for
illnesses associated with exposure to radiation. In fiscal year 2012,
the President's Budget requests $765M from Project BioShield balances
to support these priorities.
While the imminent threat of H1N1 influenza has subsided, avian
influenza viruses continue to circulate, and critical work continues to
prepare for the next influenza pandemic. One of the functions of the
Centers for Innovation in Advanced Development and Manufacturing
mentioned earlier, in addition to providing development and
manufacturing of medical countermeasures to CBRN threats, will be to
expand domestic pandemic influenza vaccine manufacturing surge
capacity. HHS continues to develop flu antiviral drugs and vaccines and
a more robust domestic vaccine manufacturing capability. We are focused
on ensuring the Nation has access to safe and effective vaccine as soon
as possible following the start of an influenza pandemic. We continue
to implement strategies that work toward producing influenza vaccine
more rapidly during an influenza pandemic, including the development
and implementation of more rapid testing methods for vaccine release
and the establishment of domestic recombinant and cell-based vaccine
manufacturing capabilities. Supporting this effort, shortening the
timeframe for vaccine availability with new and faster product testing
and next generation influenza vaccines made in the United States will
achieve better products faster. I am pleased to inform you that we are
already making great progress in these efforts.
hhs has significant accomplishments since the enactment of pahpa
We have accomplished much since the passage of PAHPA and were able
to respond to a number of public health emergencies including:
The first pandemic in 40 years;
An earthquake in the western hemisphere's poorest country;
The largest oil spill in history;
The 2011 Japan earthquake, tsunami, and associated
radiological contamination event; and,
Other domestic events including hurricanes, floods, and
tornadoes.
In addition, as I mentioned previously in my testimony, we were
also successful in procuring and stockpiling medical countermeasures to
protect against CBRN threats, as well as against pandemic influenza and
other emerging infectious diseases.
Since I was sworn in as the Assistant Secretary for Preparedness
and Response, one thing has been clear--the investments we've made in
the last decade have had a positive effect on our ability to respond to
emergencies. In each response, HHS provided support to State, local, or
international partners and in return learned valuable lessons to guide
future response operations. We are working internally to strengthen and
incorporate the lessons learned from these and other recent responses
to ensure future response efforts are enhanced.
The Japanese earthquake and subsequent nuclear reactor crisis is an
example of a catastrophic scenario that would present formidable public
health and healthcare challenges to the United States should such an
event occur here. We already knew the importance of deploying medical
countermeasures as quickly as possible following an incident. However,
as a result of this crisis, we have expedited efforts internally to
ensure adequate countermeasures are stockpiled and can be deployed as
soon as possible following incidents. It is critical that we have the
flexibility to use and deploy countermeasures as soon as possible
following the start of a public health incident to help reduce
morbidity and mortality.
Beyond medical countermeasures, many lessons learned during our
2009 H1N1 pandemic response will strengthen HHS's ability to respond to
other emergency events. The 2009 H1N1 experience stressed the
interdependence of the public health, pre- and post-hospital care,
primary care, hospital care systems and community and business
organizations. It also confirmed the need for a ``whole of community''
approach in planning and responding to a disaster, and confirmed that,
going forward, we must address the entire healthcare community in our
preparedness activities. The Department is considering proposals to
strengthen the ability for medical and public health professionals to
be of assistance in an emergency situation.
Lastly, after our response to the Haiti earthquake we have taken
actions to: streamline internal operations to ensure providers are
adequately supported; provide needed services quickly and efficiently
following disasters; and, ensure we have access to information that
supports surveillance of the spread of illness. I am pleased to inform
you that we have been working to strengthen the National Disaster
Medical System (NDMS). NDMS is a federally coordinated system closely
linked to the Hospital Preparedness program that augments the Nation's
medical response capability. The primary purpose of the NDMS is to
supplement an integrated National medical response capability for
assisting State and local authorities in dealing with the medical
impacts of major peacetime disasters. NDMS now uses an Electronic
Medical Record (EMR) system that standardizes recordkeeping and
promotes enhanced health surveillance during disasters. This, and other
enhancements we have made, enable us to better identify population
needs as we respond, including in the area of pediatrics. These
developments in identifying the needs of populations, specifically
pediatric and at-risk populations, will support a better and more
focused response in the future.
All of the accomplishments I have just described were supported
through the close collaboration of many HHS partners including CDC,
NIH, FDA, ASPR as well as the Centers for Medicare and Medicaid
Services (CMS), the Substance Abuse and Mental Health Services
Administration (SAMHSA), and the Indian Health Service (IHS), just to
name a few.
HHS has a number of programs and tools that aid State and local
response and coordinate efforts during disasters. The ASPR Hospital
Preparedness Program (HPP) has advanced the preparedness of hospitals
and communities in numerous ways, including through planning for all-
hazards, increasing surge capacity, tracking the availability of beds
and other resources using electronic systems, and developing
communication systems that are interoperable with other response
partners. We recently issued a report on the Hospital Preparedness
Program that describes the achievements of our State partners in
building healthcare preparedness across the Nation, and illustrates how
States have used the capabilities developed and funded through the
program in both large and small incidents. One specific accomplishment
detailed in this report is that more than 76 percent of hospitals
participating in the HPP met 90 percent or more of all program measures
for all-hazards preparedness in 2009. This is a significant
accomplishment and clearly demonstrates participants' commitment to
investing in preparedness. Copies of this report were provided to each
member of the committee in advance of this afternoon's hearing.
In addition to HPP, CDC's Public Health Emergency Preparedness
(PHEP) cooperative agreements provide funding to enable State and local
public health departments to have the capacities and capabilities to
effectively respond to the public health consequences of not only
terrorist threats, but also infectious disease outbreaks, natural
disasters, and biological, chemical, nuclear, and radiological
emergencies.
To promote coordination and efficient use of resources, we are
working together to determine the best path forward for alignment of
the HPP and PHEP grant programs to ensure we are efficient with
resources and that we eliminate duplicative or conflicting programmatic
and administrative efforts for grantees. Once we complete our internal
alignment process, we will engage interagency partners to examine
additional opportunities for synergy with other Federal preparedness
grants. Consistent with Presidential Policy Directive 8, we are working
toward a framework for priority-setting, review, and reporting
measures; development of a common pathway to focus dollars, measure
outcomes, reduce duplication, and enhance return on investment and
reporting; and enhanced data sharing for improved situational awareness
during a response.
PAHPA authorized the HPP and PHEP grant programs. These programs,
as I have just mentioned, are critical to ensuring State and local
jurisdictions have the tools and resources to prepare for public health
incidents.
conclusion
The experiences since the passage of PAHPA have shown clearly that
every part of the public health and medical community is critical to
building resilience. We applaud Congress' wisdom in enacting PAHPA as
the foundation for this approach, which is so critical to our
preparedness.
At this time I would be happy to address any questions you may
have.
Senator Casey [presiding]. Doctor thanks very much. I
appreciate your testimony. We will have questions and we will
do it in the order that the Senators arrived. I will start with
Senator Blumenthal and then I will take myself out of the line
up temporarily, for questions, and we will go to Senator Burr
and then Senator Hatch.
Senator Blumenthal.
Statement of Senator Blumenthal
Senator Blumenthal. Thank you very much, Mr. Chairman and
thank you for your work on this issue which has been
instrumental and Senator Burr as well. And thank you for being
here, Dr. Lurie.
I have a number of questions raised by your written
testimony. First, you speak briefly about some of the thermal
burn countermeasures, and I know that you have focused on this
issue. I wonder if you are satisfied that we have procured
sufficient quantities and quality? Whether HHS and BARDA has
done enough to ensure there are sufficient quantities and
quality, because I think they are vital to have in our national
stockpile.
Dr. Lurie. Thank you for that question.
One of the very important things that PAHPA did was provide
us the flexibility and funding to be able to do advanced
development of products. I think at first we thought maybe we
could just go out and buy them or that, you know, having a fund
for procurement would be enough of an incentive for industry to
come and make all the products that we need.
It turned out that there really wasn't very much in the
pipeline. And I think thermal burns is a great example of where
there really wasn't very much in the pipeline to start. And so
we have really had to, as I think you know, reach back in the
system and have developed, through Dr. Robinson and BARDA, a
very sophisticated advanced research and development program so
that we can develop these products to the point that they could
at least be used under emergency use authorization, not through
licensure and then procure it through the stockpile.
Senator Blumenthal. Do you think there is a bottleneck in
either the development or the procurement process? And if so,
where would it be?
Dr. Lurie. The Secretary's Medical Countermeasures Review
took a really hard look at this last year and we identified a
number of bottlenecks in the process and have now set to work
on each of these and maybe sort of taking them in some order.
The first really comes from taking early concepts at NIH and
pulling them through to a point where the developers can get
the help they need to be ready for an advanced development
process.
A second has to do with the way we support companies. And
you know that the President's budget is seeking authority for
what we are calling a strategic investor, to help companies
leverage venture capital and on the business end to be able to
move some of these forward.
A third major area, for example, is in the area of
regulatory science. And I think we have all recommended a
fairly big push here in the area of regulatory science.
I could go on and on about bottlenecks, but I will also
just comment that we have made pretty radical changes in how we
do the governance of the medical countermeasures inside. And so
already in doing that I think we have eliminated a number of
the bottlenecks and already been able to speed up our
contracting processes.
Senator Blumenthal. I thank you for that answer and I will
follow up perhaps to seek additional information. I want to
sort of switch topics.
As a member of the Armed Services Committee I am aware of
the 2006 Quadrennial Defense Review and its focus on the need
for a more integrated military/civilian response in this area.
And I know it is not directly within your purview, but I
wonder, as the point person, so to speak, on the overall
emergency issue, would you agree that there is a need to
formalize the pathway for improving a civilian/military
integrative response?
Dr. Lurie. I think actually we have been making tremendous
progress in that area. In the countermeasures development end
of this we have an integrated portfolio where we and DOD sit
together and talk about what to do. We now formally have
liaisons between our two offices so that we can coordinate
better. And we actively work with our DOD partners on a number
of issues including patient movement in a disaster and worked
closely with them in Haiti.
You know, right now the large national level exercises
going on around, ironically, an earthquake on the New Madrid
fault and speaking at this moment we are exercising patient
movement with our DOD colleagues.
Senator Blumenthal. My time has just about expired but I
have one last, quick question and I would like to followup on
this one as well. I have become very concerned about the
shortages of certain kinds of pharmaceutical drugs for
hospitals, which seems to be quite alarming and increasingly
prevalent, in Connecticut and around the country. And I wonder
if that issue is one that has been factored into your planning
for emergency preparedness.
Dr. Lurie. It is something that we look at quite a bit and
we have a whole critical infrastructure protection program that
looks at this, including partnerships with private sector
companies, big box stores so that we can look at the
availability of products. We started a whole initiative to be
able to do a better job tracking products through the pipeline.
But I agree with you, that there is a lot more work to do here
and I would love to be able to follow up with you about that.
Senator Blumenthal. Thank you. Thank you very much, Dr.
Lurie and thanks for your great work in the department.
Dr. Lurie. Thank you.
Senator Blumenthal. Thank you, Mr. Chairman.
Senator Casey. Thank you, Senator Blumenthal.
Senator Burr.
Senator Burr. Thank you, Mr. Chairman. My hope is, and I
pledge to Senator Blumenthal, if the committee will look into
the drug shortage I will be right there with him.
Senator Blumenthal. Thank you.
Senator Burr. I think it falls well outside the space that
we are here to talk about today, but indeed it is a problem and
it is a problem that leads us then to the FDA and to other
areas that need examination by this committee and other
committees.
Nicki, welcome. Let me just ask you, one of the most
important questions of the PAHPA legislation was this
determination of who is in charge and we chose, when we wrote
it, that we would create this new entity and it would in fact
be the Assistant Secretary for Preparedness and Response. I
would like you to sort of share with us, in your own words,
describe what it is you do.
Dr. Lurie. That is a great question and I thank you for it.
And I also want to thank you, again, for the wisdom in
determining that there really needed to be a focal point for
this issue and leadership in the department, really somebody in
an office that focuses on preparedness day-to-day and
coordinates all of the HHS aspects of response.
Let me talk first about the response end of things and then
go back to the other end of things. In response, the Assistant
Secretary for Preparedness and Response is in charge of
coordinating the HHS aspects of emergency response and working
with the rest of the interagency. So we stand up, through our
Secretary's operations center, for all of our components.
Thanks to PAHPA, the National Disaster Medical System is moved
back to us and we are prepared to mobilize a very robust health
and public health response.
At the same time we mobilize the policy components of the
response so that there is rapid decisionmaking and coordination
across all of the department. I kid you not when I say that
every aspect of the department, ranging from the Agency for
Child and Families to the Office of Refugee Resettlement or the
Agency on Aging has been involved with us in response.
Between disasters, and often during them, we look at how we
can better prepare, whether it is through our healthcare system
preparedness or public health preparedness, strengthening our
NDMS and strengthening our medical countermeasures enterprise
and working on a set of policies related to that. Again, all of
these involve a tremendous amount of coordination across the
department with our partners at CDC, NIH, FDA, SAMSA, etc. and
with the interagency partners such as DHS, DOD, the VA and
others.
I think having this focal point for leadership has proved
to be really important. And I would like to think that the way
that we have handled all the responses in the past 2 years has
been a real testament to that.
Senator Burr. You alluded to the relationship with these
other agencies and I think it is important for members to
understand that there are certain things that we moved under
your jurisdiction and we moved them from these other agencies.
But, you are a customer to them from a standpoint of what
threats might exist, because that is determined at----
Dr. Lurie. Yes.
Senator Burr [continuing]. The Department of Homeland
Security. And there are other aspects that are controlled at
the Centers for Disease Control. Are there areas that you feel
would be beneficial in addressing the comprehensive nature of
your role that we should look at as we reauthorize this to move
out of other agencies and consolidate within your direct
supervision?
Dr. Lurie. I think it is a really good question. I think as
we have worked through particularly the countermeasures aspects
of this over the past couple of years, I think we have
developed a much closer and more collaborative relationship
with DHS on the issues that relate to the determination of
threats. And I think we have been able to make much more robust
our requirement setting process so that we actually can work
much more collaborative with the other agencies around setting
those requirements and then actually doing the research and
development and getting the countermeasures made and licensed.
Likewise, we've worked much more closely with DOD in the
integrated portfolio aspects of this.
Senator Burr. I agree we have made tremendous strides with
DOD. But let me just point this out publicly, creating your
slot was to have a single individual we could look at when
there might have been a breakdown and say, ``Okay, it is your
responsibility, what happened.'' So as we go through this
reauthorization, if in fact there are areas that we need to
look at, legislatively, that need to move to or from where they
currently are, I sort of put you in charge of letting us know
before we get this legislation done. If not, you have areas
that you have no control over that we are going to point to you
as the--or to whoever is in your slot--as the person to
directly hold responsible. And they are going to say, ``You
know, I didn't have jurisdiction over it. Tell us now.''
Dr. Lurie. Fair enough. I appreciate that very much and
will continue to give it some thought and be happy to talk more
about it.
Senator Burr. During the H1N1 pandemic the government made
a substantial commitment to adjuvants to the Strategic National
Stockpile, however today an adjuvanted vaccine could only be
made available under an emergency use authorization since it
has not been approved by the FDA. Adjuvanted seasonal influenza
vaccines have been used in Europe for over 12 years. Last year
the President's Council on Advisors on Science and Technology
issued a report recommending, ``a goal of approving a minimum
of two adjuvant vaccines in the next 2 years.'' We are almost a
year into this recommendation, without approval of an adjuvant.
Given the potential public health benefit of this
technology for patients for both seasonal and pandemic
influenza vaccines, how will you ensure the approval of
adjuvants is appropriately prioritized?
Dr. Lurie. Great question. We have invested and are
continuing to invest in the development of safe and effective
adjuvants and understand that adjuvants may be--well be one of
the answers to more effective influenza vaccines going forward.
My understanding right now is that FDA is poised to act on
applications for adjuvanted vaccines when they receive them.
And I think for a seasonal flu vaccine that is the current
situation. We are continuing to work very closely with FDA to
move along products in the regulatory pathway and pipeline. We,
as I commented before, have been really redoing the way we do
some of the governance, so there should be fewer delays and
fewer surprises when things get to that point. And the
investment in regulatory science ought to help FDA be able to
do a lot of the things it needs to do in the regulatory area,
faster and better.
Senator Burr. Thank you. Mr. Chairman, you have been kind
with the time.
Let me just point to members something that the Secretary
has alluded to and I mentioned briefly and that is the
emergency use authority that is required for nonFDA-approved
product to be used. We have products in the stockpile today
that are yet to be FDA approved. They can only be used if there
is an emergency use authorization. So, given that it is very
difficult to determine how you expedite things at the FDA, and
I am being generous in the way I said that, and hopefully
diplomatic, it is very important that members understand we are
going to have quite a discussion before PAHPA reauthorization
comes up, about whether we need to redefine emergency use
authority and whether we set a new threshold for that.
If we don't, we could find ourselves in a situation that we
have a real threat, we have an inability to respond in a timely
fashion and much like we were faced with H1N1 where there were
some delays in emergency use authorization, we actually had
kids in this country die because we couldn't initiate that fast
enough. And there is no one person that is to blame, it is a
process that had never thought through the speed with which we
might need to do that. And I just warn the members to flag that
as we move forward.
I thank the Chair.
Senator Casey. Thank you, Senator Burr.
Senator Roberts.
Statement of Senator Roberts
Senator Roberts. Thank you, Mr. Acting Chairman, the
Senator from New Jersey--or pardon me, Pennsylvania. You can be
New Jersey too if you would like. Start a trend.
[Laughter.]
Senator Casey. Senator, I would note for the record, our
witness was educated at the University of Pennsylvania.
I just want to throw that in.
Senator Roberts. All right.
[Laughter.]
That is why she is so learned and uses those 25, 35 cent
words in the right place. I am going to ask a follow up on the
Richard Burr dynamite question, and I want to thank Senator
Burr for really highlighting this. He was very generous in his
comments and diplomatic. Obviously I won't be.
In your testimony you suggest a need for an increased
investment in the regulatory sciences and review capabilities
at FDA focused on pandemic influenza, chemical, biological,
radiological, nuclear and medical countermeasures, I might toss
in agra-terrorism, but I am told by staff not to do that.
At any rate, can you be more specific on the Senator's
question and my question on what you mean by investment in the
regulatory sciences and the review capabilities. Do you mean
more funding for FTE folks, or do you mean--what? What do you
mean?
The reason I am asking is that I don't think we are--we
lack specificity in the guidelines for FDA and what we don't
need is additional regulations. I don't know whether you want
the full-time employees and I am not sure what that means in
terms of investment in regulatory sciences and review
capabilities.
We have to speed this up. The Senator is exactly correct, I
come from the Ag Committee and we go over all sorts of threats
all the time to the Nation's food supply. If that happens, it
happens. We can't just wait until that happens and then try to
figure out what to do. As a first responder, it is the sheriff
out there usually in one of my small towns in Kansas.
I am talking more rather than listening. Would you like to
respond?
Dr. Lurie. I would defer to the FDA about the FTE issue.
But I would observe that as we did the countermeasures review
one of the things that we heard, both from FDA and from our
partners in industry, was an issue that if you would get to the
end of the line you would want to move a product forward for
licensure and the science to be able to do that just wasn't
there. That is not the time to think about doing the science.
And because you are from Kansas and talked about animals, I
will talk about the animal rule in that regard. You know, we
have a notion that for things that can't be tried in people, it
would be a good idea to test them in animals under the animal
rule. But it turns out, for example, that we don't have really
good animal models, because we haven't invested in the science,
as an example, to figure out how to use that most effectively
so that we can do the science to know if a product is going to
be safe and effective and move it on toward licensure. The same
thing with different kinds of assays, the same thing with
different kinds of staff and expertise, for example. So that
investment in science is really intended to speed up the--and
clarify a number of the regulatory issues involved.
I know we had a discussion internally just last week about
new diagnostics. For example, for flu vaccine. In order for FDA
to be able to look at those and regulate them, there is
probably some science that needs to get done first. And we
ought to be doing it now, so 2 or 3 years from now, when those
products are ready to come to FDA we are ready to meet the
companies where they are.
Senator Roberts. If you can put a little Zocor or Lipitor
in the pipeline so we don't have so much cholesterol, that
would be very helpful.
[Laughter.]
Many of the recommendations and suggested changes for
consideration during the reauthorization also suggest a need
for additional resources, of which we don't have any.
Considering the current and economic and fiscal crisis, if you
had to prioritize these suggestions, which would you say is the
No. 1 need?
Dr. Lurie. Prioritize which suggestions?
Senator Roberts. Which one would you say is the No. 1 need?
Of the recommendations of the suggestions, of the changes for
consideration during the reauthorization, in the entire
reauthorization bill, what is your No. 1 priority goal, given
the limited resources that we have?
Dr. Lurie. I actually think you are asking me to choose
among my children here. And as the mother of three boys that is
probably a dangerous thing to do.
Senator Roberts. Yes, it is.
Dr. Lurie. But I would offer a couple of things. I would
offer that continuing to focus on our Medical Countermeasure
Enterprise is critically important. I would offer that
strengthening day-to-day systems in public health and
healthcare preparedness are also really, really critical as we
go forward here.
Senator Roberts. I thank you very much. Thank you for the
job you are doing.
Dr. Lurie. Thank you.
Senator Roberts. Thank you, Mr. Chairman.
Senator Casey. Thank you, Senator Roberts.
I might jump in here. I was second on the list, so I gave
up my spot. But let me just----
Senator Roberts. Thank you.
Senator Casey. Let me just present a couple of questions to
Dr. Lurie. First of all, thanks for your service in a tough
time to be in government but also having the significant and
burdensome responsibilities you have. We are grateful for that.
I wanted to highlight, and I know you have addressed this
today and at other times, but I wanted to highlight some of the
process here to see where you are. Instead of using the
acronym, I will read it all, the Pandemic and All Hazards
Preparedness Act was passed, part of that, as you know better
than I, was the implementation or the anticipated
implementation of the National Health Securities Strategy. Can
you give us kind of a brief sense of where that is in the
process?
And we know that over these years, I guess 5 years now
roughly, there have been reports and reviews and studies
concluded that inform what we are doing on these. And there are
lots of ideas out there. But how do you report to us (a) on the
progress of--or the timeline for the implementation plan, but
also, (b) how do you incorporate all these other reviews or
studies into that kind of a plan?
Dr. Lurie. Great question. And we very much appreciated the
opportunity to develop the National Health Security Strategy.
It is the first really of its kind and that was released
December 2009, on time. We have been working through,
punctuated by a few disasters, completing the biennial
implementation plan which has been out for public comment and
is just about done.
At the same time, we haven't waited for the implementation
plan to begin to implement in a number of areas. As you know,
the strategy is wide ranging and lays out really a set of
capabilities for our Nation to be prepared and health secure.
So whether it is through the Public Health Emergency
Preparedness or the Hospital Preparedness grants, we have
already begun, for example, to incorporate many of the concepts
from the National Health Securities Strategy into grant
guidance.
The National Securities Strategy places a big focus on
building community resilience, so there is a lot of work going
on there, same with strengthening emergency preparedness and
response systems. And our work with NDMS and others has
continued to move us in those directions.
So, a lot of the implementation is going on as the plan is
being written. It is on track and I think we are moving
forward.
Senator Casey. I was noting in your testimony, I want to
read it verbatim, on the bottom of page 2 when you describe
your mission. You say, and I am quoting that your mission is
defined as,
``leading the country in preparing for, responding to
and recovering from health effects of emergencies and
disasters by three things really, supporting our
communities' ability''--communities' abilities, I
should say--``to withstand adversity, strengthening our
health and response systems and third, enhancing
national health security.''
That is a tall order for any person or any group of folks
working on these difficult preparation, response and recovery
issues. I would ask you kind of a basic question that is
probably on the minds of a lot of citizens, but also those who
are enacting public policy or legislating in this area. What do
you feel most secure about in terms of the work you have done
to date, in terms of your work as it relates to our own
security?
What keeps you up at night? What worries you the most in
terms of not just the threats, there are plenty of them that we
can all imagine and articulate. But I am not talking about what
worries you about the threat, I want to know more about what
are you most worried about in terms of our preparation and our
response to what we know are a long list of significant
threats.
Dr. Lurie. Right. No, it is a great question and I do feel
like we have made a lot of progress over the last decade and I
think we still have a lot of progress to make.
I would glibly tell you that if I didn't sleep at night I
couldn't do my job during the day. But the things that I worry
most about, No. 1, are a threat that we have never thought
about and anticipated before coming our way, our ability to
recognize it when we see it and to act quickly on it. That is
why there is so much focus on the rapid, nimble, flexible
capacity to make a countermeasure against something we have
never seen before.
It is also why we have placed so much focus on capabilities
rather than planning for scenarios, what capabilities do we
need to have in place so that we can mix and match and pull off
a shelf and respond to whatever comes our way. It is building
those capabilities that I think is terribly important. Those, I
think, are really the issues that keep me up at night.
The other thing that keeps me up at night is knowing that
the Federal Government can't do this all alone, you know, that
our State and local partners and our private sector partners
are in this with us and indeed the National Health Securities
Strategy lays that out. In these really tough financial times
when everybody is kind of stretched to the limit, I actually
worry that we could backslide on some of our progress and that
would be a dangerous situation for us to be in.
Senator Casey. I'm over my time, and I want to turn to
Senator Whitehouse. But, let me just ask you this. If you had,
as you do in hearings like this, the opportunity to say, ``I
need x, or we need x'', to complete the mission that I just
read from and outlined from your testimony, what would you hope
you would have that you don't have now in terms of authority
and then more particularly, tools or the removal of impediments
that we all know are part and parcel of often what we try to do
in the Federal Government.
Dr. Lurie. I think we are here because the authorities in
PAHPA are so important and I think we need to continue and
reauthorize those authorities that we have, maybe with a little
bit of tweaking around the edges to be able to act on some of
the lessons learned and do some of the things that we need to
do a little bit better. I think the authorities that we have to
make and procure countermeasures continue to be really
important and things that we need to reauthorize.
And then we need to work very closely with our partners
around the country, some of whom are represented on the next
panel. You know, whether it is State and local public health,
the healthcare community, industry, faith-based organizations
or others, because as I said, we are all in this together at
the end of the day. It is really my responsibility to keep all
the spinning plates up in the air, to keep us all together and
coordinated and moving forward, working together there.
Senator Casey. Senator Whitehouse.
Statement of Senator Whitehouse
Senator Whitehouse. Thanks, Chairman Casey and welcome, Dr.
Lurie.
Just to take off on your last answer about the unforeseen
threat and our capacity to, as you said--have a rapid, flexible
and nimble capability to build a medical countermeasure. How do
you evaluate our current capabilities for rapid response in the
event of an attack using an unknown biological agent? How can
we facilitate this rapid, flexible and nimble development of
medical countermeasures? And is the new advanced development
and manufacturing initiative at BARDA adequate to meet those
standards?
Dr. Lurie. Great question. So I think the first thing I
would say is the first challenge that we face is the ability to
recognize, as quickly as we can, that this threat is upon us,
to be able to detect it, figure out what it is so that we know
what to do about it. And that is an issue of strengthening our
public health and surveillance systems, not just at the CDC but
both internationally and--
Senator Whitehouse. We are going to go into that in a
moment. But go on ahead to the development of the
countermeasures.
Dr. Lurie. So in the development of the countermeasures,
the move toward advanced development and manufacturing the
flexible, nimble capacity, the way to get there, we believe, is
through the initiatives outlined in the Medical Countermeasures
Review including the advanced development and manufacturing
facilities which we think will be central to being able to do
that.
Senator Whitehouse. How do you keep the biggest players who
are the custodians of yesterday's technology from using their
political brawn and their economic might to crowd out new
entrants who may actually have a better technology but would
cause economic harm to the bigger players if they are--if that
competition were added into the mix? What is the way in which
you particularly look out for the new technologies and keep the
process from being captured by those who have a vested interest
in the status quo?
Dr. Lurie. What we look out for and we look for those new
technologies through the Concept Acceleration Program at NIH.
Through, if authorized, the strategic investor, so that we
can--and we can put different kinds of investments into those
new players and those new technologies. Also new are the
technology but not necessarily the business skills to be able
to pull it off and get to where they need to get to, then
through providing those core services through the advanced
development and manufacturing facilities so that they can
actually take their projects to scale and move forward to a
point where we are able to move to a full product development
and licensure.
So those are all different ways in which we want to look
out for the innovators and welcome any and all innovation to
the table and be sure that the playing field is level for them.
Senator Whitehouse. And is the BARDA process--how would you
evaluate that in this light?
Dr. Lurie. I think the BARDA--remember, BARDA got stood up
from scratch a couple of years ago. I think the BARDA process
is working incredibly well. I would note that compared to where
we were a couple years ago, we now have 70 projects under
advanced development, which is really stunning considering that
we started at zero. So I think it is working quite well and we
have identified ways to make it even more nimble and more
welcoming for innovators.
Senator Whitehouse. And back to your point about the
ability to detect the threat in the first instance. The draft--
Biennial Implementation Plan from July 2010 specifically
mentions linking your National Health Security infrastructure
into the developing National Health Information infrastructure
which got such a boost from the American Recovery and
Reinvestment Act. And it specifically mentions incorporating
the role of health information exchanges to advance real-time
information dispersal.
Rhode Island is one of the States that is at the forefront
of developing health information exchange. It is a very
difficult thing to develop. And compared to the value to be
returned on a successful health information exchange, I think
we are very under-invested in supporting the HIE, the Health
Information Exchange development, particularly out at the head
of the trail where the real work is being done.
I am wondering what you see as your role, from a public
health perspective, in trying to support and facilitate the
development of these health information exchanges. At the local
level, are you working with ONCHIT on this? Are you engaged in
that part of it? How important do you see this as a priority?
Dr. Lurie. We work with ONC all the time, including around
the sort of constructs that relate--and the regs that relate to
meaningful use and how to move forward. It was really
interesting, during the pandemic, what you saw were some real
breakthroughs, consistent with the CDC's bio-surveillance
strategy in how we use real-time healthcare data to do
surveillance, to do, tracking of antiviral prescriptions, to do
a number of things.
I agree with you that there is a long way to go, but I
think over the past year we have started to see a lot of
progress in that area. We will continue to work very closely
with ONC going forward.
The other place we work with them, by the way, is in the
electronic health record for the National Disaster Medical
System, another place that enables us to have real-time
situational awareness of what is happening in a disaster and to
be able to pivot quickly if we need to.
Senator Whitehouse. Thank you. Thank you, Mr. Chairman.
I know that Pennsylvania has been a real leader in this
area as well. But as we transform from a health information
infrastructure that basically has computers on doctors' desks,
but you still have to go out and get the information from the
hospital, from the lab, from the pharmacy, from the imaging
place, from the specialist into a really integrated health
information infrastructure, the Health Information Exchange is
the key infrastructure that links all that together. And that
is really, I think, going to be the accelerator in terms of our
ability, from a safety and cost savings perspective, or a
public health perspective, to have rapid access to that
information so that we can do that early detection. And so I
hope that we will continue to focus on that and see that as an
area for investment on this public health and safety side, not
just through the ONC. Thanks very much.
Senator Casey. Thanks, Senator Whitehouse.
Doctor, we are going to let you go in a moment. I just have
one quick question. I think you spoke to this before, if not
directly but in part. One of the things that often will
confront the Federal Government is how you work in
coordination, the old problem with silos and the inability of
agencies or offices to coordinate and work together. It is
especially maddening to taxpayers when they have to work
together in their lives and sometimes government can't.
But when you, in terms of what BARDA does day-to-day and
then with regard to coordination, which I hope is a lot of
coordination with both FDA and NIH, just if you could, for a
moment, speak to that coordination that is so important in
getting this right.
Dr. Lurie. One of the things that we instituted since I
have been there has been both a series of what we call
portfolio reviews. So everybody sits down at the table
together, including the DOD, and shares what it is they are
doing. This was really the first time that kind of thing had
happened and it spun a whole lot of collaboration.
Going forward, working in BARDA, they are using a system
which I, as a primary care doctor, sort of call case
management. You know, we have the scientists from NIH and FDA
and CDC at BARDA sitting down, often with the developers of new
products, at regular intervals, starting at the beginning, to
identify what the issues are and work them out and work them
out often on a quarterly basis, again, so that we are
coordinated, there aren't surprises, we identify where there
are gaps that need to be filled through this portfolio review
process. And again, it is my job to bring everybody together to
coordinate and get those gaps filled.
I have been actually quite pleased with how it is working.
I am sure it is a work in progress, that we can continue to do
better. Quality improvement has been one of the centerpieces of
sort of how I do business in our office and will continue to
adapt that philosophy to continue to make things better and
better.
Senator Casey. Doctor, thank you very much.
Dr. Lurie. Thank you.
Senator Casey. We appreciate your testimony and your
service.
Dr. Lurie. Thank you. It has absolutely been an honor to
serve the American people in this time.
Senator Casey. Thank you.
Now we will move to our second panel and maybe as we are
getting organized, I can, with the assistance of Senator Burr,
read through some of the biographical and background material
for our next panel.
Senator Burr, would you like to start or--I have the
introductions of three, but Dr. Kadlec, would you like to do
that first?
Senator Burr. I would love to do that.
Senator Casey. Great, thank you.
Senator Burr. It is an honor and a privilege to introduce
Dr. Bob Kadlec who many on this committee affectionately call
Dr. Bob. I have had the pleasure of knowing Bob for many years.
He served our Nation in many distinguished capacities. He
served 26 years as a military officer and physician in the
United States Air Force, serving in senior positions in the
White House, the Department of Defense and as a senior staffer
here in the U.S. Senate.
Dr. Bob is a veteran of Operation Desert Storm and Iraqi
Freedom. His military decorations include the Bronze Star and
the Joint Distinguished Meritorious Service Medal with Hope
Leaf Cluster. Until January 2009 Bob served as a special
assistant to the President and senior director for bio-defense
policy on the Homeland Security Council. Dr. Bob is currently a
member--or a director in public health practice at PRTM.
I am also told--and I can see her now--I am pleased to say
that Dr. Bob's wife, Dr. Ann Vertis, and his daughters,
Margaret and Samantha, are in attendance today. I am glad to
see that you could join us. Let me say to your daughter's, Bob,
you should be very proud of your dad and the work he has done
to protect the American people and serve this Nation.
I look forward to your testimony, Bob, as I do to the rest
of our witnesses today.
STATEMENT OF ROBERT P. KADLEC, M.D., MTH&H, MA, VICE PRESIDENT,
GLOBAL PUBLIC SECTOR, PRTM MANAGEMENT CONSULTANTS, WASHINGTON,
DC
Dr. Kadlec. Thank you, Senator Burr, for that very generous
introduction. I have to admit my family is here as part of my
human shield program.
[Laughter.]
It is great to be back in the familiar setting such as
this, Mr. Acting Chairman, members that are here today. And
also know that it is a very different viewpoint from this side
of the dais than up there. And so I am very sensitive to that,
but really what I hope to focus in on, and my comments will be
very brief and to the point. One thing that I would like to
just mention, that in my military career I spent a long part of
that in the special operations community for which I had the
privilege to serve with many joint special operation activities
and units, but the thing I took away from that critical thing
was the necessity for unity of command, and I will get to that
point a little bit later on.
I just want to start out by saying there is nothing more
sacred than protecting and defending the constitution of this
country. But I would say a very close second is protecting and
saving American lives in the event of a deliberate attack on
our Nation. And that is obviously what the conversation here is
today and I believe it is something that all members of
government, all parties, all branches of government certainly
have as a sacred duty.
And with that, in preparing for this testimony, I really
spent a little time looking at the history of this issue, the
issue for preparing our country for national security
emergencies, and found that there was an Executive Order,
11490, and I am sure nobody remembers it, signed by Richard
Nixon in 1969, that was the predetermining step before he
actually renounced the Offensive BW Program in the country. And
that Executive order, which placed health and education and
welfare department in charge of responding to public health
emergencies, that was the result from radiological, chemical or
biological events, was reaffirmed by Reagan in 1988, Clinton by
1998 and obviously during the Bush administration several
presidential directives and Executive orders were yielded.
But I want to point out the essential role of Congress in
this, because if you look at the history of this, very little
measurable progress was done. And I don't want to say we lived
the Einstein definition of insanity, but clearly these
Executive orders didn't have the power or weight behind them to
do what was needed. And yet, in 2000, before the events of 9/
11, this committee, this Congress and Members of the House
basically started a very deliberate, incremental movement with
the passage of the Public Health Preparedness Act in 2000 (just
to note, the chairman, Chairman Harkin, Senator Enzi were part
of that, Representative Burr, I think he is related, sir, did
it from the house side), but the point is beginning before this
they recognized this as a serious issue.
And then since 2000 until the PAHPA Act was passed six
major pieces of legislation were passed by this Congress. And
so the whole notion that the power of authorization, oversight
and appropriations are key to basically addressing this issue.
I certainly applaud the efforts by this Chairman and the
Ranking Committee Members and certainly Senator Burr and
Senator Casey, yourself and the other Members, to basically
take this task forward.
The one thing I want to point out and the three areas that
I think deserve special attention is, when this was created--
the ASPR--it was really about leadership, leading the effort
around Emergency Support Function Number Eight subject to
training, organizing, equipping the health assets of the
country, primarily Federal, to basically respond to
catastrophic events.
I would say that we have made some half steps in that
direction, but quite frankly, we are not there yet.
It does take some scrutiny to look at the entities within
HHS that don't necessarily formulate that critical operational
control or span of control for Dr. Lurie as she sits here
today. If you ask, who deploys the Strategic National Stockpile
or who makes decisions on those kinds of issues, I think you
would be surprised by the answer. It is essential that someone
be in charge, as Senator Burr has said. And it is essential
that that person have the authority and powers within that
position to do the necessary things.
Senator Blumenthal asked a very insightful question,
subject to the issue of DOD and I would add also VA in that
respect. We have huge health assets that should be mobilized,
on call to support the response to a major catastrophic event
in our country and yet we don't have that necessarily in place.
The second issue is about the State and local public health
infrastructure and you will hear from others about the parties
around that, other than much of the progress that has been made
in the last decade could be lost based on the attrition, based
on the tremendous physical pressures, as well as the aging
population of the workforce as we go forward.
And the third element here, as quite a bit of the
discussion has already really been around the Medical
Countermeasures Enterprise, but the notion that is, and this is
extraordinary and a credit to the people at BARDA, that they
have been able to basically produce a number of products, get
them in the stockpile and basically operate at a budget that
has been somewhere between 20 percent to 40 percent of their
actual authorization. I wouldn't expect that our SEALS would do
as well against Osama bin Laden or any of our forces would do
as well if we only funded them at 40 percent of their funding
level.
I think with that, I am just left with the great awe and
appreciation for what this Congress has done, this committee
has done in the past. If there is any group in Congress that
gets this problem and knows how to get it done, it is the HELP
Committee. And I think under the leadership of the Chairman and
the Ranking Member, as well as you, Senator Casey and Senator
Burr, I am convinced that we will have further success and make
further progress. Thank you.
[The prepared statement of Dr. Kadlec follows:]
Prepared Statement of Robert P. Kadlec
summary
Reauthorizing the Pandemic and All Hazards Preparedness (P.L. 109-
417) and Project BioShield (P.L. 108-276) Acts is a timely and urgent
national security issue. Much progress has been achieved through the
implementation of both laws. It is a priority to further refine and
improve the overall state of all hazard public health and medical
preparedness and response.
Despite the death of Bin Laden, the threat of domestic terrorist
attacks using Chemical, Biological and Radio-Nuclear (CBRN) agents
remains a serious concern. In February 2011, the Directors of CIA and
NCTC both testified that Al Qaeda and Al Qaeda of the Arabian Peninsula
are intent on conducting attacks using CBRN agents. The head of the
FBI's WMD Directorate stated that there is a 100 percent probability of
a terrorist WMD attack on the United States. Both Senators Harkin and
Lugar publicly expressed their concern about the risk of bioterrorism
following the death of Bin Laden.
The challenge associated with deliberate CBRN attacks particularly
involving biological agents should not be confused with natural disease
outbreaks. Insights learned from the former U.S.-offensive biological
weapons program indicate that biological attacks can have the lethal
equivalence of a thermo-nuclear weapon. Unlike Mother Nature, a
deliberate thinking enemy could employ multiple biological agents in
overwhelming doses that are resistant to common treatments. Responding
to bioterrorism requires a speed and complexity of effort that is
greater than what would be likely needed in natural disease outbreak.
There are 3 areas that should receive consideration as part of this
reauthorization process:
1. Strengthen the role and responsibilities of the HHS Assistant
Secretary of Preparedness and Response (ASPR). The original intent
creating the ASPR was to put ``someone in charge'' of public health and
medical preparedness and response. As in military or special
operations, unity of command is essential to ensure an effective
response to protect and save American lives during an attack or
influenza pandemic. Despite efforts to date, the lines of operational
command and policy oversight within HHS and across the relevant
Interagency remain unclear.
2. Maintain a capable public health and medical infrastructure to
respond to catastrophic events. Recent fiscal crises at the State and
local levels have severely impacted that state of preparedness and
response with the loss of highly trained and qualified personnel.
Continuation of Public Health Emergency Preparedness and Hospital
Preparedness Grant programs is essential to maintain needed
capabilities.
3. Promoting a robust medical countermeasure (MCM) development,
manufacturing and distribution and dispensing enterprise. HHS should be
required to submit multi-year budget plans for MCM development and
procurement and authorized to accelerate MCM development. Further
measures should be enacted to support companies developing CBRN MCM
that have no or limited commercial market overcome the funding and
regulatory challenges. Efforts underway to improve the speed of
dispensing MCM to augment existing modalities should be accelerated to
improve preparedness and response. These should include utilizing
approaches such as the U.S. Postal Service home delivery; development
of FDA approved medkits and first responder pre-event anthrax
vaccination.
______
Chairman Harkin and Senator Enzi, it is a distinct privilege and
pleasure to appear before you today. The reauthorization of the
Pandemic All-Hazard Preparedness Act (PAHPA) is a timely and urgent
issue. In the course of the intervening 5 years since its passage; many
of this law's provisions have been implemented and in many cases
resulted in improvements in our overall preparedness and response for
all-hazard incidents. No doubt, there are some provisions that have not
resulted in what Congress envisioned and deserve reconsideration.
Further, the recent review conducted by the Obama administration
following the H1N1 Influenza Pandemic evaluating the status of the
medical countermeasure enterprise, has identified opportunities for
further improvements to the advanced development, regulatory support
and manufacture of certain medical countermeasures. The results of this
review are also worthy of consideration during this process. This
hearing and reauthorization process is also timely in light of the
anticipated expenditure of the $5.6 billion advanced appropriations
contained in the Project BioShield Special Reserve Fund. Hopefully your
deliberations will seriously consider reauthorizing this important act
as well.
There is urgency to these efforts as well. The death of Bin Laden
is an important inflection point in the war against Al Qaeda and
Islamic extremism. As President Obama has explicitly stated, the threat
from terrorism has not abated. Mr. Chairman, you and Senator Lugar
recently highlighted the potential increased risk of bioterrorism
following Bin Laden's death.
I note other recent authoritative statements by key Intelligence
and FBI officials as reason for continued concern that should lead to
urgency to improve our preparedness and response for a range of
possible conventional and unconventional attacks. In February of this
year, both the Central Intelligence Agency (CIA) Director Leon Panetta
and National Counter-Terrorism Center (NCTC) Director Michael Leiter
highlighted their concern about continued high interest by both Al
Qaeda and Al Qaeda of the Arabian Peninsula to obtain and use
radiological materials in dirty bombs, or chemical or biological
agents, particularly anthrax, in attacks. Dr. Vahid Majidi of the FBI
WMD Directorate rated the probability of a WMD attack in the United
States at 100 percent, either from a known terrorist group or an
unknown ``lone wolf '' actor. In light of Bin Laden's demise, there
should be a greater urgency about correcting deficiencies. In some
cases, as in the development or manufacture of certain medical
countermeasures (MCM) or addressing manpower shortages in critical
public health or medical professions; there is a significant lead time
to rectify shortfalls.
While we have recently experienced significant natural disasters or
accidents, they do not reflect the risk of a catastrophe from a
deliberate WMD attack by a thinking enemy. Insights learned from the
former U.S.-offensive biological weapons program highlight several
important considerations. The impact of an aerosolized biological agent
attack can have the lethal equivalence of a nuclear weapon.
Adversaries, States, groups or even individuals, who are intent to use
such weapons will do so with the specific intent to defeat one's
defenses through the potential delivery of multiple virulent agents,
overwhelming infectious doses, antibiotic resistant strains or all the
above. The belief that deliberate attacks are similar to or less
challenging than natural emerging disease pandemics is not only false
but dangerous.
Though the title of this Committee on Health, Education, Labor, and
Pensions, doesn't reflect it; the issue of preparedness and response is
vital to national and homeland security. Unfortunately, your efforts
don't receive the press or notoriety of your colleagues on the Armed
Services, Homeland Security and Intelligence Committees. I suggest that
your efforts here today and the weeks and months ahead can build on
PAHPA's achievements and advance preparedness and response. I suggest
that there are three areas that should receive your particular
attention, consideration and effort.
1. Strengthen the role and authorities of the Assistant Secretary
of Preparedness and Response (ASPR) in the Department of Health and
Human Services (HHS). The original intent of legislation was to put
``someone'' in charge of medical and public health preparedness and
response. Second only to protecting and defending the Constitution,
protecting and saving Americans whose lives are threatened from
potentially catastrophic attacks or natural disasters is a sacred
obligation. The model used to create the ASPR was the one used to
create the military Regional Combatant Commanders. In advance of a
contingency, they set the requirements for the forces that would be
committed in the event of hostilities. Should a contingency occur, that
regional combatant commander would assume operational control of those
assets and prosecute the mission under a unified command structure.
This doesn't mean that units are physically moved, it means the
operational scheme is pre-determined and that those capabilities are
trained and equipped to ensure success.
Prior to the creation of the ASPR, no one was in charge and no one
was accountable for public health or medical preparedness and response.
That is what the ASPR was created to do. It is a tall order in a non-
national security Department like HHS to immediately embrace or
transform itself in such a fashion. However, the ASPR was the result of
careful and thoughtful consideration to consolidate these functions
under one person who is presidentially appointed and confirmed by the
Senate to ensure that American lives can be protected and saved should
a catastrophe happen. As with any transformational change, progress
comes haltingly. The objective should never be forgotten: Protecting
and saving American lives from the threat of weapons of mass
destruction or pandemics is the ASPR's sacred duty.
The ASPR should have the necessary policy oversight and operational
control in the event of or anticipation of a public health emergency of
all the HHS elements, including CDC response and designated Inter-
agency assets under Emergency Support Function Eight of the National
Response Framework during an anticipated or actual public health
emergency. This goal has not been fully achieved but is essential to
ensure the success of this mission.
2. Maintaining a capable public health and medical infrastructure
to respond to catastrophic events. Much progress has been achieved
through the funds authorized and appropriated to the Public Health
Emergency Preparedness and Hospital Preparedness Grant programs. Mr.
Chairman, I particularly recall your vision of creating a national
public health system that was similar to our national highway system:
standardized, interconnected, and promoting not only public health but
national security. You will hear from others concerning the incredible
strain that the recent fiscal crisis has wreaked on State and local
public health programs, particularly concerning the retention of
qualified personnel. People are the cornerstone of public health
preparedness and response.
3. Promoting a robust medical countermeasure (MCM) development,
manufacturing, distribution and dispensing enterprise. Much effort and
attention was recently given to the issue of MCM development and
manufacturing. During the H1N1 pandemic, deficiencies in our ability to
rapidly produce vaccines were noted. The recently announced Medical
Countermeasure Initiative by HHS highlights some important
opportunities to improve the process by which the Government subsidizes
the development and production of these necessary products. While there
has been much focus on the threat of pandemic influenza, I am concerned
that the challenges and risk around the development of national
security MCM for chemical, biological and radio-nuclear threats remains
high. Despite limited advanced development funding, BARDA has had
several notable successes including developing and stockpiling Bavarian
Nordic's smallpox vaccine, Human Genome Sciences anthrax monoclonal
antibody and SIGA's and Chimerix's smallpox antiviral drugs. More
should be done to assist companies who are attempting to navigate the
difficult funding and regulatory pathways while developing vital
national security MCM that have no or limited commercial market. Simply
requiring HHS to develop and submit multi-year budget plans outlining
their priorities and intended procurements would go a long way to
assist both Congress and companies involved in this endeavor. Further,
BARDA should have the resources necessary to conduct a robust advanced
development portfolio and have the flexibility to accelerate advanced
development of select products as required. BARDA's efforts and budget
should reflect the priority of creating MCM for national security.
There also needs to be clear requirements concerning what should be
our policy in the event of either a credible threat of or actual
biological attack. In response to the threat of smallpox, the United
States has stockpiled enough vaccine for every American and now is
stockpiling antiviral drugs. We will soon be able to take smallpox
``off the table'' and go on to create a credible deterrent against this
threat. We have not made similar policy determinations for other
potential threats. The recent Fukushima disaster starkly highlights a
policy decision as to whether we should pre-position potassium iodide
in metropolitan areas at risk for nuclear or radiological attacks.
These policy requirements are essential to guide decisions concerning
not only procurement but building adequate capacity to produce the
range of CBRN vaccines and biological products that may be needed in a
crisis.
The proposal to improve the FDA's ability to assist such companies
and provide the necessary dedicated regulatory support is an important
initiative that deserves congressional backing. Ensuring BARDA has the
necessary means to conduct its support of and the ability to accelerate
advanced development remains a serious shortfall in the overall U.S.
Government approach in producing national security MCM.
Significantly, there remain serious shortfalls in our capabilities
to rapidly distribute and dispense MCM in the event a deliberate
attack. I note that President Obama signed an Executive order in
December 2009 instructing Federal Departments and Agencies to examine
how they can assist State and local authorities to more rapidly
dispense MCM to populations that may be affected by CBRN attacks. An
essential measure that was identified is the forward deployment of MCM
so they can be rapidly accessed by essential first responders, health
care workers and the public. There are a range of options that should
be aggressively pursued including development of medkits for use by
first responders, their families and available to the public; utilizing
existing distribution systems with the U.S. Postal Service and retail
pharmacies; and options for vaccinating first responders against the
most likely threat of anthrax. There is an urgent need to act now to
prepare to prevent the potential significant loss of life, social chaos
and loss of confidence in the U.S. Government in the event of an
attack.
I very much appreciate the opportunity to appear before you all
today and look forward to your questions.
Senator Casey. Doctor, thank you very much for your
testimony and for your work on these important issues.
I want to note for the record, I should have said this
before, that of course all of the witnesses testimony, if you
wanted to submit something in writing you can do that as well,
that will be made a part of the record if you submit it, in
addition to anything that you obviously say by way of summary.
What I will do next is I will introduce our next three
witnesses by way of biography and background and then we will
start picking up the testimony again with Phyllis Arthur.
Let me add as well, any panelist who wants to introduce
members of your family, all of us realize that when someone
serves in public office, appointed or elected, that the family
serves as well, so they deserve recognition and commendation.
Next, and I am moving from left to right here, next is
Phyllis Arthur. Phyllis, we welcome you. Ms. Arthur is the
senior director for vaccines of immunotherapeutics and
diagnostic policy at the Biotechnology Industry Organization,
known as BIO. And Ms. Arthur is a recognized expert in the
field of vaccines. Before joining BIO she worked in marketing
and sales in the vaccine division at Merck and Company. And
through her career she has launched several new vaccines in the
United States and abroad, most notably Gardasil, the first
vaccine for HPV. We appreciate your presence here and your
testimony, Phyllis Arthur.
Next, Dr. Michael Anderson. Dr. Anderson is the vice
president, associate chief medical officer at University
Hospitals in Cleveland. In addition to his leadership position
Dr. Anderson serves as the associate professor of pediatric
critical care at Rainbow Babies & Children's Hospital. In 2008
Dr. Anderson was appointed to the National Commission on
Children and Disasters. And as a member of this commission, he
was charged with analyzing our readiness to care for children
in disasters and issuing recommendations to the President and
to the Congress. Welcome, Doctor.
And finally, Ms. Susan Cooper. Susan Cooper is the
commissioner of Tennessee's Department of Health. She is the
first nurse to serve in this capacity. Commissioner Cooper has
a wealth of public health and emergency preparedness
experience. She has helped develop Tennessee's healthcare
safety net and programs addressing the threat of Type 2
Diabetes. Commissioner Cooper also serves on the executive
committee of the Board of Directors of the Association of State
and Territorial Health Officials. Ms. Cooper, thank you very
much--or Commissioner, I should say.
I think we will go back to Ms. Arthur, if you wanted to
provide your testimony. And again, if any of you want to
introduce family, you have that option. Thank you.
STATEMENT OF PHYLLIS ARTHUR, SENIOR DIRECTOR, VACCINES,
IMMUNOTHERAPEUTICS AND DIAGNOSTICS POLICY, BIOTECHNOLOGY
INDUSTRY ORGANIZATION, WASHINGTON, DC
Ms. Arthur. Thank you. Good afternoon. Thank you for that
nice introduction, Chairman Casey, Ranking Member Burr. I will
say I am a graduate of the University of Pennsylvania, so I
will give that shout out.
Members of the committee, ladies and gentlemen, as stated,
I am Phyllis Arthur, with BIO. BIO represents a broad mix of
companies involved in the research, development and manufacture
of biologicals, including products for the detection,
diagnosis, treatment, prevention, and delivery of medical
countermeasures, or MCMs, in response to chemical, biological,
radiological and nuclear threats.
These companies consider themselves integral partners with
the U.S. Government in the development of these vital
countermeasures that are needed to protect the American people.
And therefore, BIO has focused its recommendations on changes
that are essential to both attract and of course retain
companies in the Enterprise. Over the last 10 years, as
Assistant Secretary Lurie pointed out, bipartisan congressional
efforts have created and funded an MCM Enterprise that has
begun to show success.
In partnership with industry the U.S. Government has
responded to the 2009 H1N1 pandemic, prepared for a possible
pandemic of bird flu, made numerous improvements to existing
flu production and issued contracts on a host of different
platforms for strategic treats, including delivering two key
countermeasures for smallpox and anthrax to the Strategic
National Stockpile. Presently there are more than 50 companies
conducting research and development in influenza vaccines in
over seven different platforms. In addition, there are 25
companies, actually maybe more, that are currently working on
new treatments, vaccines and diagnostic countermeasures related
to CBRN threats.
Developing CBRN countermeasures can be even more complex
than influenza. First the targeted diseases are less well
understood. Second, determining the best development pathway to
demonstrate safety and efficacy requires a great deal of
scientific collaboration between industry and the key Federal
agencies, especially in special populations such as children
and pregnant women. Third, many bio-threats are complex and
unique and they may require specific diagnostic tools, vaccines
and treatments requiring separate, detailed clinical plans.
BIO has identified three key priorities to improve
preparedness and reduce the time to develop and approve
essential countermeasures. First, provide greater transparency
and clarity in the MCM market, the contracting process and in
advanced research and development activities. Second, improve
the clarity, consistency and integration of the FDA in the
development and approval of MCMs. And third, ensure the future
of the Enterprise while simultaneously reauthorizing Project
BioShield and Special Reserve Fund with PAHPA.
The Project BioShield Act accomplished several important
goals, including the creation of the Special Reserve Fund which
is designed to guarantee companies that the government will
purchase new, successfully developed countermeasures for the
SNS. The existence of the SRF and the annual appropriations to
BARDA define the marketplace for MCMs, because there is not a
viable commercial market for these products. Company resources
allocated to countermeasures divert R&D and manufacturing away
from commercial products and they must be subjected to the same
rates of return. In addition, private investors are wary of
investing in this type of research.
So BIO recommends that HHS be required to provide biannual
reports outlining BARDA advanced development activities and the
length of time to BioShield requirements and procurement
awards. BIO also recommends greater transparency in BARDA and
BioShield contact requirements, including the early
establishment of required product characteristics.
One of the most significant risks unique to countermeasures
development is certainly the testing and the clinical trial
design requirements. These are less well-established. Clinical
trials often require the use of multiple animal models to prove
human efficacy and this adds to the uncertainty. The most
significant recommendation from the PHEMCE review was to invest
in the FDA and its review and regulatory science processes.
This would enable FDA to have an affirmative role in solving
the scientific and regulatory hurdles of MCMs.
BIO and its members strongly support this recommendation
and encourage the FDA to work collaboratively with company
sponsors throughout the entire MCM process to help design
development plans and associated studies, especially those
requiring the use of animal models. Implementation of new MCM
initiatives should be coupled with specific measurements for
success.
The Project BioShield Act and PAHPA help to build processes
to advance clinical and manufacturing infrastructure to protect
against a multitude of biological threats. In addition to
developing and stockpiling countermeasures, devices and
diagnostics against currently anticipated threats, it is
crucial that the United States build the capacity to respond to
novel threats, such as newly emerging diseases and genetically
modified pathogens. The reauthorization of PAHPA and BioShield
SRF are critical to these efforts.
Therefore, BIO strongly urges Congress to simultaneously
reauthorize the SRF with PAHPA. The SRF should be funded at a
level that incentivizes private industry to actively
participate. Furthermore, Congress should clearly articulate
that development of MCMs is a national security priority and
that funding for these efforts be treated as national security
spending.
Since 2001 the Enterprise has had some successes. However,
much remains to be done. Future planning and sustained
investment in global surveillance networks, our public health
infrastructure, MCM development and distribution systems is
critical to adequately alert, prevent and recover from any
future CBRN or natural biological event.
BIO commends the committee for holding this hearing and we
stand ready to work with Congress to implement these important
issues. Thank you.
[The prepared statement of Ms. Arthur follows:]
Prepared Statement of Phyllis Arthur
BIO represents a broad mix of small, medium and large companies
that develop and manufacture biological products for the detection,
diagnosis, treatment, prevention and delivery of countermeasures in
response to chemical, biological, radiological and nuclear (CBRN)
events.
Over the last 10 years, bipartisan congressional efforts have
created and funded a Public Health Emergency Medical Countermeasure
Enterprise (PHEMCE) that has begun to show success. In partnership with
industry the U.S. Government:
Responded to the 2009 H1N1 pandemic;
Invested in products to prepare for a possible bird flu
pandemic;
Completed a comprehensive review of influenza vaccine
production issues;
Issued contracts for novel platforms for seasonal and
pandemic influenza vaccines, diagnostics and antivirals as well as the
final development of novel treatments for smallpox, new antibiotics and
innovative treatments for the side effects associated with acute
radiation syndrome (ARS); and
Acquired and delivered key countermeasures to vaccinate
against smallpox and treat anthrax to the Strategic National Stockpile
(SNS).
Among the goals of the U.S. Government in conducting the medical
countermeasure (MCM) review issued in August 2010 were identifying
issues limiting companies of all sizes from successfully engaging in
the countermeasures process and proposing solutions to increase
engagement. BIO has identified three key priorities that will help
achieve a greater degree of industry participation and urges the
committee to consider incorporating them into the legislation to
reauthorize the Pandemic All-Hazards and Preparedness Act (PAHPA) of
2006. Priorities include: (1) providing greater transparency and
clarity in the MCM market establishment, the contracting process, and
in advanced research and development activities; (2) improving the
clarity, consistency and integration of FDA in the development of MCMs;
and (3) sustaining the MCM market by ensuring that Project Bioshield
and the Special Reserve Fund (SRF) are simultaneously reauthorized with
PAHPA.
(1) defining a viable market value for mcms
Project BioShield was designed to serve as a symbol of the U.S.
Government's commitment to purchase new, successfully developed
countermeasures for placement in the SNS. The acquisition and
contracting processes at HHS to acquire new countermeasures are viewed
by industry partners of all sizes as lengthy, opaque, and
unpredictable. BIO recommends greater transparency in BARDA/BioShield
contract requirements including the early establishment of product
characteristics required. BIO also recommends that HHS be required to
provide bi-annual reports outlining BARDA advanced development
timelines/activities and the length of time to BioShield procurement
award and that appropriate action be taken if timelines are not met.
(2) management of cost and risk and the regulatory process for mcms
The development of countermeasures is a unique, resource-intensive
and complex process that can be costly and fraught with risk. One of
the most significant risks is that countermeasures are approved via a
convoluted regulatory pathway. Testing and clinical trial design
requirements are not well-established, requiring the use of multiple
animal models to prove efficacy, which adds an extra dimension of risk
and uncertainty to this process.
BIO and its members strongly support making significant investments
in FDA review and regulatory science initiatives related to medical
countermeasures. FDA should play an affirmative role in solving the
scientific and regulatory hurdles that exist, not just the review and
approval, of MCMs. This can best be accomplished by encouraging the FDA
to work collaboratively with company sponsors throughout the entire MCM
development process to design development plans and associated studies,
especially those requiring use of animal models.
BIO recommends that the FDA become more involved in the development
of MCMs through a combination of planning and coordination activities
and implementation of specific measurements for MCM initiatives.
(3) sustainability of the mcm market
The Project BioShield Act and PAHPA helped to build processes to
advance clinical and manufacturing infrastructure to protect against a
multitude of biological threats. While there have been successes in
several strategic portfolios, currently the United States is decades
away from having an adequate arsenal of countermeasures to safeguard
our citizens. The reauthorization of PAHPA and the replenishment of the
BioShield SRF are critical to these efforts.
Therefore BIO strongly urges Congress to reauthorize the Special
Reserve Fund simultaneously with the reauthorization of PAHPA. The SRF
should be funded at a level that incentivizes private industry to
actively participate in the MCM process and should be designated as a
national security or homeland security priority.
______
Good morning Chairman Harkin, Ranking Member Enzi, members of the
committee, ladies and gentleman. I am Phyllis Arthur, senior director
for Vaccines, Immunotherapeutics and Diagnostics Policy at the
Biotechnology Industry Organization (BIO). BIO represents more than
1,100 companies, academic institutions, State biotechnology centers and
related organizations in all 50 States.
In the area of biodefense, BIO represents a broad mix of small,
medium and large companies involved in the research, development and
manufacture of medical countermeasures or MCMs. These companies develop
and manufacture biological products for the detection, diagnosis,
treatment, prevention and delivery of countermeasures in response to
chemical, biological, radiological and nuclear (CBRN) events.
One of the goals of the Department of Health and Human Services'
(HHS) review of the Public Health and Emergency Medical Countermeasures
Enterprise (PHEMCE) was to identify and solve those issues limiting
companies of all sizes from successfully engaging in the countermeasure
process. In its input on both the HHS PHEMCE review and reauthorization
of the Pandemic and All-Hazards Preparedness Act (PAHPA) of 2006, BIO
has stressed one overarching principle: the biopharmaceutical industry
wants to be an integral partner with the U.S. Government in the
development and stockpile delivery of these vitally important
countermeasures to protect the American people. Therefore BIO has
focused its recommendations on changes that are essential to both
attract and retain companies of all sizes to the Enterprise.
Maintaining the skills and know-how of companies that have already
weathered the complicated MCM development and contracting process must
be as important to the U.S. Government as attracting new companies to
the MCM development space.
BIO has identified three key priorities to improve preparedness,
accelerate approvals and reduce the time needed to develop essential
MCMs. We urge the committee to address these areas in the
reauthorization of PAHPA. These include: (1) providing greater
transparency and clarity in the MCM market establishment, the
contracting process, and in advanced research and development
activities; (2) improving the clarity, consistency and integration of
FDA in the development and approval of MCMs; and (3) ensuring that the
future of the PHEMCE is adequately funded by simultaneously
reauthorizing Project Bioshield and the Special Reserve Fund (SRF) with
PAHPA.
investments have yielded success
Over the last 10 years, bipartisan congressional efforts have
created and funded an Enterprise that has begun to show success. Some
of the most important accomplishments involve pandemic influenza
preparedness. Not only did government agencies and industry partners
mount a well-thought out response to the 2009 H1N1 pandemic, they also
invested in products to prepare for a possible avian/bird (H5N1)
pandemic and conducted a comprehensive review of influenza vaccine
production issues. This review resulted in the President's Council of
Advisors on Science and Technology (PCAST) report in August of 2010.\1\
This report made important and attainable recommendations for both
existing and future technology to meet the challenges of responding to
future pandemics. Some of these are currently being implemented, but
all should be fully considered and supported with adequate resources.
---------------------------------------------------------------------------
\1\ Executive Office of the President, President's Council of
Advisors on Science and Technology, Report to the President on Re-
engineering the Influenza Vaccine Production Enterprise to Meet the
Challenges of Pandemic Influenza, August 2010.
---------------------------------------------------------------------------
Currently, there are more than 50 biotechnology companies
conducting research and development in new seasonal and pandemic
influenza vaccines in over seven different novel technologies and
platforms. Other companies are developing new antivirals and diagnostic
tools as well. While the Biomedical Advanced Research and Development
Authority (BARDA) has invested in new manufacturing facilities and
issued new contracts for several of these innovative platforms, more
investment at every phase of development is vital from both the public
and private sectors if America wants to realize our full potential.
Developing countermeasures to respond to bioterrorism threats is
even more complex than influenza. First, the targeted diseases are less
well-characterized and studied, especially in special populations such
as children and pregnant women, and the study of these diseases often
relies on complicated animal models. Second, how the MCM will be used
in response to an attack determines how it should be designed and
clinically studied. Thus, determining the best development pathway to
demonstrate safety and efficacy requires a great deal of scientific
collaboration between industry and the key Federal agencies. Third, for
each unique biothreat, the goal is to have a diagnostic tool to
identify the threat as well as countermeasures to prevent illness and
others to treat those who become infected. Lastly, many of the
technologies being applied for medical countermeasures are relatively
new themselves. They hold great promise as methods to solve the pivotal
clinical issues that these threats pose, but they also require more
significant investment at every research stage to help increase the
probability of success.
Despite these challenges there have been some successes in the
development and procurement of MCMs for the treatment and prevention of
lethal biothreats, such as anthrax, botulinum toxin and smallpox. In
the past 2 years, key countermeasures to vaccinate against smallpox and
treat exposure to anthrax have been delivered to the Strategic National
Stockpile (SNS). Furthermore, several key procurement and advanced
development contracts have been issued that will lead to the final
development of novel technologies for smallpox, new broad spectrum
antibiotics and innovative treatments for the side effects associated
with acute radiation syndrome (ARS).
recommended actions
BIO has identified three challenges that limit industry's
participation in PHEMCE and we urge Congress to address them in the
PAHPA reauthorization: (1) defining a viable market value for MCMs
versus the opportunity cost of investing in alternative therapeutic
areas; (2) management of cost and risk, especially in the regulatory
process; and (3) the sustainability of the market over time.
(1) defining a viable market value for mcms
The Project BioShield Act of 2004 accomplished several important
goals, but the most significant was the creation of the Special Reserve
Fund. BioShield is designed to guarantee companies that the government
will purchase new, successfully developed countermeasures for placement
in the Strategic National Stockpile. The existence of the SRF and the
annual appropriations to BARDA, which support MCM advanced development
and CDC procurement funding, define the marketplace for MCMs. Companies
consider the amount of resources available through BARDA and the SRF
when comparing the opportunity cost of pursuing the development of a
specific countermeasure. The time and company resources allocated for
these products diverts R&D and manufacturing resources away from
commercial products and must be subjected to the same rates of return
analysis. In addition, private investors place little to no value on
this type of research as the market is difficult to calculate,
development and contract award projections are seldom met, and the
guarantee of government purchase is not always clear. Therefore, there
are very limited external private funds to support companies in the MCM
space.
Another part of the opportunity cost assessed by industry is the
time required to achieve success. While industry, particularly small
biotechnology companies, finds BARDA a good and effective partner, the
acquisition and contracting functions to acquire new countermeasures
are viewed as lengthy, opaque, and unpredictable. The trigger to
transition a program from advanced development to procurement is
unclear. Target dates to complete contract awards are typically not met
and some acquisitions are delayed by months, years, or even canceled.
The negotiation process is lengthy and the rationale and potential
triggers for contract options are unclear. The signal to industry is
that despite the enormous risks of development, new drugs and vaccines
developed as countermeasures have far less value than commercial
products.
BIO recommends that HHS be required to provide bi-annual reports to
Congress outlining BARDA advanced development activities and the status
of achieving key milestones, the length of time to BioShield
procurement award, and other BioShield procurement activities. BIO also
recommends greater transparency in BARDA/BioShield contract
requirements including the early establishment of required product
characteristics.
(2) management of cost and risk and the regulatory process for mcms
The development of countermeasures is a unique, resource-intensive
and complex process that is costly and fraught with risk. One of the
most significant risks is that countermeasures are approved via a
convoluted regulatory pathway. Similar to commercial biologicals, new
countermeasures can take 8-12 years to develop at a cost of $800
million to $1 billion, and failure is common at all stages of
development. Yet in most other ways MCM development and approval is
much more complicated. Testing and clinical trial design requirements
are less well-established, requiring the use of multiple animal models
to prove efficacy, which adds an extra dimension of risk and
uncertainty to this process.
One of the most significant recommendations from the PHEMCE review
was to invest significantly in the FDA review and regulatory science
processes. BIO and its members strongly support this recommendation,
and have worked to ensure FDA was allowed a transfer of money for such
purposes as part of the fiscal year 2011 FDA appropriation. The FDA has
tremendous expertise in the science of drug development and the
manufacturing of complex drugs, diagnostics and biologics. The lack of
full integration across the Enterprise, especially as it pertains to
the approval process for countermeasures, has in several instances, led
to significant delays and the need for unexpected regulatory actions by
companies in order to achieve licensure for a product. Effectively
integrating FDA into the MCM development efforts will ensure that the
government can have more rapid access to fully licensed medicines,
devices and diagnostics for national security threats in a cost-
effective manner.
To meet this goal FDA needs to be given an affirmative role in
solving the scientific and regulatory hurdles, not just the review and
approval, of MCMs. This can best be accomplished by encouraging the FDA
to work collaboratively with company sponsors throughout the entire MCM
development process to design development plans and associated studies,
especially those requiring use of animal models. The current structure
and resources provide a disincentive for FDA to spend time on these
complex issues in partnership with industry. Additionally, BIO
recommends that FDA funding targeted to improving MCM efforts should be
linked to measurable metrics.
BIO recommends that the FDA become more involved in the development
of MCM's through a combination of planning and coordination activities
and implementation of specific measurements for MCM initiatives.
(3) sustainability of the mcm market
The Project BioShield Act and PAHPA helped to build processes to
advance clinical and manufacturing infrastructure to protect against a
multitude of biological threats. While there have been successes in
several strategic portfolios within HHS, currently the United States is
decades away from having an adequate arsenal of countermeasures to
safeguard our citizens. In addition to developing and stockpiling
countermeasures against currently anticipated threats, it is critical
that the United States build the capability to respond to novel threats
such as newly emerging diseases and genetically modified pathogens. The
U.S. Government can help increase the Nation's preparedness by
undertaking several other key actions.
First, the reauthorization of PAHPA and the BioShield SRF are
critical to these efforts. Therefore, BIO strongly urges Congress to
reauthorize the Special Reserve Fund simultaneously with the
reauthorization of PAHPA. The SRF should be funded at a level that
incentivizes private industry to actively participate in the MCM
process.
Furthermore, Congress should clearly articulate that development of
MCMs is a national security priority and that funding for these efforts
be treated as national security and/or homeland security spending.
Second, BIO recommends that Congress formally establish a process
by which HHS and its relevant agencies (NIH, CDC, FDA and ASPR) develop
an integrated 5-year plan that can be shared with all stakeholders.
Ineffective coordination and collaboration between the various
government agencies involved in the Enterprise adds to the overall
uncertainty surrounding MCM's. The prioritization of threats is not
transparent so it is not clear which pathogens, platforms, indications
and target populations are the most important. Indeed one government
agency may view these threats in different ways from the others, thus
leading to conflicting, or overlapping, programs with differing
priorities.
The PHEMCE review highlighted the importance of a 5-year plan for
the Enterprise with goals tied to measurable outputs and outcomes. Due
to the long development timelines for biological products, industry
partners need to be able to plan and communicate with their investors
on the anticipated value and impact of MCM projects with some increased
level of certainty. A systematic, transparent vision from the U.S.
Government will help companies assess the viability of both their
existing and future countermeasures' programs. This multi-year
strategic plan, coupled with modifications to the contracting
processes, would encourage increased industry participation.
Third, BIO recommends the continued investment in distribution and
public health infrastructure. Both the PHEMCE review and the PCAST
report on Pandemic Influenza considered the breadth of the preparedness
continuum--surveillance, rapid manufacturing of MCMs, diagnosis, and
ultimate delivery to the public. In order to benefit the public, the
U.S. Government must know when and how to deploy and administer
countermeasures. Some of the PHEMCE and PCAST recommendations will
require longer-term investments, such as training public health and
medical first-responders, while others can be implemented in the near-
term through more effective planning and with modest resources. For
example, stockpiling strategies for products that are applicable to
many different emergencies--such as needles, syringes, and critical
assay compounds, can ensure rapid availability and avoid supply chain
disruptions.
Lastly, one of the most critical elements of responsiveness
involves the Nation's ability to detect and identify these threats to
best mount a proper and timely response. BIO members are also concerned
that the U.S. Government makes the right investments in global and U.S.
surveillance testing and reporting networks. Efforts should be made to
extend the network and to invest in and explore common platforms and
design tools that can increase efficiency and reduce costs. Improving
interagency coordination within the U.S. national network, while
striving to modernize its technical and technological capabilities,
would increase speed and accuracy in detecting emerging diseases and
threats.
improving the mcm process requires sustained partnership
Because there is no viable commercial market for most MCMs, it is
essential for Federal, State and local governments to be involved in
the detection of threats and the development and dissemination of the
products in the event of an emergency. As is true with typical
biologics development, it takes many products in development to arrive
at one successfully licensed vaccine, antimicrobial or diagnostic test.
If our collective goal is to use innovative technology to help solve
vital national security issues, then everyone must be willing to
acknowledge the higher degree of risk and uncertainty inherent in MCM
development. Future plans and investments are pivotal to sustain
current successes and further strengthen and improve the Nation's
preparedness.
BIO commends the committee for holding this important hearing and
stands ready to work with Congress on these important issues. BIO
strongly encourages the committee to improve preparedness and
accelerate development and approval of essential MCMs by: (1) providing
greater transparency and clarity in the MCM market establishment, the
contracting administration process, and in advanced research and
development activities; (2) improving the clarity, consistency and
integration of FDA in the development of MCMs; and (3) ensuring that
Project Bioshield and the Special Reserve Fund are simultaneously
reauthorized with PAHPA.
Over the last 10 years, bipartisan congressional efforts have
created and funded a public health emergency medical countermeasure
enterprise (PHEMCE) that has begun to show success. It is critical that
future plans and investments be made that will build upon this success.
Senator Casey. Thanks, Ms. Arthur.
Dr. Anderson.
STATEMENT OF MICHAEL R. ANDERSON, M.D., FAAP, VICE PRESIDENT
AND ASSOCIATE CHIEF MEDICAL OFFICER AT UNIVERSITY HOSPITALS AND
ASSOCIATE PROFESSOR OF PEDIATRIC CRITICAL CARE AT RAINBOW
BABIES & CHILDREN'S HOSPITAL, CLEVELAND, OH
Dr. Anderson. Good afternoon, Mr. Chairman and members of
the HELP Committee. I am Dr. Michael Anderson, a practicing
pediatric intensive care physician at Rainbow Babies &
Children's Hospital in Cleveland.
None of my family members are here, although last week I
was here with about a million eighth graders on a bus. So I
feel that my family has been in town recently.
Up until April I was also proud of serving as vice chairman
of the National Commission on Children and Disasters, a
commission created out of the strong leadership of this
committee.
On behalf of the American Academy of Pediatrics, I would
like to thank you for holding today's hearing on such an
important topic, strengthening our medical and public health
preparedness and response.
Recent events in Alabama, Mississippi, Louisiana and the
Chairman's own State of Iowa, make today's hearing especially
timely. These events and the tragedy in Japan are a stark
reminder that disasters can and do strike, oftentimes obviously
without warning. Therefore, as a Nation, as individuals and
families and importantly as healthcare professionals we must
plan ahead and we must be prepared.
As a clinician and someone active at the State and local
and national level on pediatric disaster readiness and
response, I can tell you that our Nation's preparedness has
improved dramatically with the legislation like PAHPA and the
Emergency Medical Services Act for Children. Through the
leadership of this committee we have made tremendous progress,
but from what I see as a pediatrician and a former
commissioner, we are not fully prepared to address the needs of
25 percent of our population, our Nation's children.
You have heard the saying that children are not little
adults. My written testimony goes into detail about why this is
the case, from a clinical standpoint. The reason it matters the
most when it comes to medical and public health preparedness is
that children live in every part of this country. When a
disaster strikes, children will show up at hospitals, not just
children's hospitals. They will need care by EMS professionals
in the pre-hospital setting. They will be in shelters, live in
temporary housing and may be separated from their parents and
caregivers. If each and every one of these settings and others
are not able to handle the unique physical and mental health
needs of children, including children with disabilities, our
work is far from finished.
The Academy supports the efforts of this committee to
reauthorize PAHPA and urges the committee to use this bill as
an opportunity to redouble our efforts at the Federal level to
prioritize the needs of children and including children with
disabilities and other vulnerable populations.
While I recognize this is a tough fiscal climate, I believe
a significant step would be to remove children from the broader
at-risk population category in the law and designate an office
with the authority and funding necessary to adequately meet the
needs of children during a disaster. This is especially
critical now that our commission has been terminated. I
appreciate the sensitivities around this recommendation, but I
continue to believe it is vitally important.
But there are many other ways that we can strengthen our
preparedness. No. 1, when it comes to medical countermeasures
for children, it would be very helpful for the Federal
Government to set a goal to achieve parity between adult and
pediatric medical countermeasures developed and included in the
SNS and other federally funded caches. Among the recent
advancement for children is the approval of pediatric labeling
for Pollodoxin for the treatment of nerve agent poisoning
meaning it can now be stockpiled in the SNS for that
indication. However, that labeling took 7 years to get
approval, with no new data. We must figure out how to
streamline that process.
Two programs this committee is very familiar with, BPCA and
the Pediatric Research Equity Act have resulted in the labeling
or re-labeling of 400 new drugs for children with new safety,
efficacy and dosing information and this is a huge advance in
the field of pediatrics. The Academy looks forward to working
with this committee to reauthorize these two vital programs and
maximize their potential to improve pediatric labeling of MCM
so that they can be stockpiled.
No. 2, volunteerism. I am proud to be a member of the
National Disaster Medical System. But the NDMS and the Medical
Reserve Corps need more clinicians. Thought should be given to
how we might make it easier for clinicians to participate and
how we might tailor pre-certification or training programs to
reach clinicians on a broader scale all while ensuring
recruitment of clinicians for specific populations such as
geriatrics, pediatrics and individuals with disabilities or
medical conditions.
Third, among the lessons learned from H1N1 is that hospital
preparedness is critical. HHS has recently announced that 76
percent of hospitals participating in the HPP program meet 90
percent of their core measures. However, a 2008 CDC study
showed that only a third of hospitals had guidelines for
pediatric surge capacity, only 34 percent had plans for
reunification of children with their families and 40 percent
had a tracking system for unaccompanied children. The
disparities in these findings is striking and I have included
several recommendations in my written testimony of how we could
deal with this.
I want to thank the committee for this opportunity. I look
forward to your questions. America's children represent the
future of our Nation and our more precious resource, they must
not be an afterthought in medical and public healthcare
preparedness and response. Thank you.
[The prepared statement of Dr. Anderson follows:]
Prepared Statement of Michael R. Anderson, M.D., FAAP
Chairman Harkin and Ranking Member Enzi, thank you for holding
today's hearing on such an important topic, strengthening our medical
and public health preparedness and response. My name is Mike Anderson,
M.D., FAAP, and I am representing the American Academy of Pediatrics, a
non-profit professional organization of more than 60,000 primary care
pediatricians, pediatric medical sub-specialists, and pediatric
surgical specialists dedicated to the health, safety, and well-being of
infants, children, adolescents, and young adults. For more than a
decade, the Academy has engaged in a broad range of activities related
to disaster preparedness, including policy statements on clinical care
and tools for pediatricians before, during, and after disaster
situations.
I am vice president and associate chief medical officer at
University Hospitals Case Medical Center and associate professor of
pediatrics at the Case Western Reserve School of Medicine in Cleveland,
OH. I am also a practicing pediatric critical care specialist at
Rainbow Babies & Children's Hospital. In my capacity as a practicing
clinician, I have been active at the local, State, and national level
in pediatric disaster readiness and response. In 2008, I was appointed
by President George W. Bush to the National Commission on Children and
Disasters (the Commission) which was created by Congress under the
strong leadership of Chairman Harkin, former Senator Chris Dodd, and
many others. I had the distinct honor of serving as the Commission's
vice chair until its termination in early April 2011.
Recent events in Alabama, Mississippi, and in the Chairman's home
State of Iowa make today's hearing especially timely and critical.
These events and the tragedy in Japan are a stark reminder that
disasters can and do strike, and oftentimes without warning. Therefore,
as a nation and as individuals and families, we must plan ahead and we
must be prepared.
The recovery and relief efforts here in the United States from
tornadoes and flooding and from the earthquake and tsunami in Japan
will take time and for countless families, especially those who lost
loved ones, life will never be the same. Recovery for the most
vulnerable of our population, children, may present several unique
challenges and it is important that we, as Americans, assess whether
the planning and exercises our government and communities engage in;
whether our medical capabilities and the training of our first
responders; and whether the preparedness of our Nation's hospitals,
Federal, State and local governments, and families, adequately account
for the needs of children and other populations in the event of a
disaster.
Unfortunately, today, the reality is that none of those systems are
fully prepared to address the needs of nearly 25 percent of the
population, children. We need to work to change this reality. The
Academy supports the efforts of this committee to reauthorize the
Pandemic and All-Hazards Preparedness Act (PAHPA) and urges the
committee to use the reauthorization bill as an opportunity to redouble
our efforts at the Federal level to prioritize the needs of children,
including children with special heath care needs.
The most significant step Congress could take to achieve this goal
would be to remove children from the broader at-risk population
category and designate an office with the authority and funding
necessary to adequately meet the needs of children during a disaster.
This is especially critical now that the National Commission on
Children and Disasters has terminated. The Commission provided the
needed, and previously lacking, focus and attention to children's needs
in disaster planning and preparedness within Federal agencies.
Additionally, removing children from the broader at-risk population
category would allow Federal agencies to better direct resources and
attention to populations such as individuals with disabilities, senior
citizens, and pregnant women.
children are more vulnerable than adults
You've heard the saying that children are not little adults. Why is
that and, more importantly, why does that matter when it comes to
medical and public health preparedness and response?
Children are particularly vulnerable to aerosolized
biological or chemical agents because they normally breathe more times
per minute than do adults, meaning they would be exposed to larger
doses of an aerosolized substance in the same period of time. Also,
because such agents (e.g. sarin and chlorine) are heavier than air,
they accumulate close to the ground--right in the breathing zone of
children.
Children are also much more vulnerable to agents that act
on or are absorbed through the skin because their skin is thinner and
they have a much larger skin surface-to-body mass ratio than adults.
Children are more vulnerable to the effects of agents that
produce vomiting or diarrhea because they have smaller body fluid
reserves than adults, increasing the risk of rapid progression to
dehydration or shock.\1\
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\1\ Committee on Environmental Health and Committee on Infectious
Diseases. Chemical-Biological Terrorism and Its Impact on Children.
Pediatrics, Vol. 118, No. 3 September 2006. http://
aappolicy.aappublications.org/cgi/reprint/pediatrics;118/3/1267.pdf.
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Children have much smaller circulating blood volumes than
adults, so without timely intervention, relatively small amounts of
blood loss can quickly tip the physiological scale from reversible
shock to profound, irreversible shock or death. An infant or small
child can literally bleed to death from a large scalp laceration.
Children have significant developmental vulnerabilities
not shared by adults. Infants, toddlers and young children may not have
the motor skills to escape from the site of a hazard or disaster. Even
if they are able to walk, young children may not have the cognitive
ability to know when to flee from danger, or when to follow directions
from strangers such as in an evacuation, or to cooperate with
decontamination.\2\ As we all learned from Hurricane Katrina, children
are also notably vulnerable when they are separated from their parents
or guardians.
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\2\ American Academy of Pediatrics. Children, Terrorism & Disasters
Toolkit. The Youngest Victims: Disaster Preparedness to Meet Children's
Needs. http://www.aap.org/terrorism/topics/PhysiciansSheet.pdf.
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Children have immature immune systems that make them more
susceptible to biological, chemical, radiological agents.
Children are also more vulnerable to radiological agents
due to their more rapid metabolic and cellular growth rates.
children have unique treatment needs
When children are critically ill or injured, their bodies respond
differently than adults exposed to similar insults. Consequently,
pediatric treatment needs are unique in a number of ways:
Children need different dosages and formulations of
medicine than adults--not only because they are smaller, but also
because certain drugs and biological agents may have adverse effects in
developing children that are not of concern for adults.
Children need different sized equipment and other medical
devices than adults. In fact, our day-to-day emergency readiness
requires the presence of many different sizes of key resuscitation
equipment for infants, pre-school and school-aged children, and
adolescents. From needles and tubing, to oxygen masks and ventilators,
to imaging equipment and laboratory technology, children need equipment
that has been specifically designed for their size.
Children demand special consideration during
decontamination efforts. Because children lose body heat more quickly
than adults, mass decontamination systems that may be safe for adults
can cause hypothermia in young children unless special heating
precautions or other warming equipment is provided.\3\ Hypothermia can
have a profoundly detrimental impact on a child's survival from illness
or injury. Additionally, a first responder wearing a Hazmat suit can be
scary for a child so decontamination systems should ideally be designed
so that parents can remain with their children and help them through
the decontamination process.
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\3\ American Academy of Pediatrics. Children, Terrorism & Disasters
Toolkit. The Youngest Victims: Disaster Preparedness to Meet Children's
Needs. http://www.aap.org/terrorism/topics/PhysiciansSheet.pdf.
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Children display unique developmental and psychological
responses to acute illness and injury, as well as to mass casualty
events. Compared to adults, children appear to be at greater risk for
acute- and post-traumatic stress disorders. The identification and
optimal management of these disorders in children requires
professionals with expertise in pediatric mental health.\4\ When
disaster strikes and these professionals are not readily available, it
may fall to the responsibility of first responders who need to be
adequately prepared, trained and equipped for children.
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\4\ Hagan, J and the Committee on Psychosocial Aspects of Child and
Family Health and the Task Force on Terrorism. Psychosocial
Implications of Disaster or Terrorism on Children: A Guide for the
Pediatrician. Pediatrics, Vol. 116, No. 3, September 2005.
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Children may be developmentally unable to communicate
their needs with health care providers. The medical treatment of
children is optimized with the presence of parents and/or family
members. Timely reunification of children with parents and family-
centered care should be a priority for all levels of emergency care.
children need care from providers trained to meet their unique needs
Because children respond differently than adults in a medical
crisis, it is critical that all health care workers be able to
recognize the unique signs and symptoms in children that may indicate a
life-threatening situation, and then possess the experience and skill
to intervene accordingly.\5\ As already noted, a child's condition can
rapidly deteriorate from stable to life-threatening as they have less
blood and fluid reserves, are more sensitive to changes in body
temperature, and have faster metabolisms. Once cardio-pulmonary arrest
has occurred, the prognosis is particularly dismal in children, with
less than 20 percent surviving the event, and with 75 percent of the
survivors sustaining permanent disability.
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\5\ Markenson D, Reynolds S, Committee on Pediatric Emergency and
Medicine and Task Force on Terrorism. The Pediatrician and Disaster
Preparedness. Pediatrics, Vol. 117 No. 2 February 2006.
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Therefore, the goal in pediatric emergency care is to recognize
pre-cardiopulmo-
nary arrest conditions and intervene before they occur. While children
represent 25 to 30 percent of all emergency department visits in the
United States, and 5 to 10 percent of all EMS ambulance patients, the
number of these children who require this advanced level of emergency
and critical care, and use of the associated cognitive and technical
abilities, is quite small. This creates a special problem for pre-
hospital and hospital-based emergency care providers, as they have
limited exposure and opportunities to maintain their pediatric
assessment and resuscitation skills. Fifty percent of U.S. Emergency
Departments (EDs) provide care for fewer than 10 children per day.\6\
The Academy, jointly with the American College of Emergency Physicians,
and the Emergency Nurses Association, issued guidelines to help
hospitals with identifying and training a pediatric advocate within
their institutions to implement certain protocols and help improve
hospital preparedness.\7\
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\6\ Gausche-Hill M, Schmitz C, Lewis RJ. Pediatric preparedness of
United States emergency departments: a 2003 survey. Pediatrics.
2007;120(6):1229-37.
\7\ American Academy of Pediatrics, American College of Emergency
Physicians, and Emergency Nurses Association. Joint Policy Statement:
Guidelines for Care in the Emergency Department. Pediatrics, Vol. 124,
No. 4 (2009): 1233-43. http://aappolicy.aappublications.org/cgi/
reprint/pediatrics;124/4/1233.pdf.
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Children with special health care needs represent 13.9 percent of
U.S. children, and 21.8 percent of households with children include at
least one child with a special health care need.\8\ Children with
chronic medical conditions, including children with special health care
needs, rely on multiple medications, medical devices, and complex
management plans, which can cause them to be at increased risk of acute
deterioration, medical errors, and suboptimal outcomes, especially in
emergency situations.\9\ These children pose unique emergency and
disaster care challenges well beyond those of otherwise healthy
children. Our emergency medical services systems and our disaster
response plans must consider and meet the needs of this group of
children.
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\8\ U.S. Department of Health and Human Services, Health Resources
and Services Administration, Maternal and Child Health Bureau. The
National Survey of Children with Special Health Care Needs Chartbook
2005-6. Rockville, MD: U.S. Department of Health and Human Services,
2007.
\9\ American Academy of Pediatrics. Policy Statement--Emergency
Information Forms and Emergency Preparedness for Children with Special
Health Care Needs. Pediatrics, Vol. 125, No. 4 April 2010. http://
aappolicy.aappublications.org/cgi/reprint/pediatrics;125/4/829.pdf.
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clinicians' role before, during, and after a disaster
Clinicians, including pediatricians, play an integral role in
disaster preparedness. From my personal experience, families view
pediatricians as their expert and trusted source of information. As
part of the network of health responders, pediatricians need to be able
to answer concerns of patients and families, recognize signs of
possible exposure to a weapon of terror, understand first-line response
to such attacks, and sufficiently participate in disaster planning to
ensure that the unique needs of children are addressed satisfactorily
in the overall process.\10\ However, the challenges that face
pediatricians and other clinicians in their daily practices are
heightened during a disaster situation.
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\10\ American Academy of Pediatrics. Policy Statement--The
Pediatrician and Disaster Preparedness. Pediatrics, Vol. 117, No. 2
February 2006. http://aappolicy.aappublications.org/cgi/reprint/
pediatrics;117/2/560.pdf.
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It is important to point out that more than 95 percent of office-
based pediatricians practice in settings defined as ``small
businesses'' by the U.S. Small Business Administration. Fifty percent
of private office-based pediatricians work in practices of 3 or fewer
physicians with 8 or fewer non-physician staff; 70 percent work in
practices of no more than 5 physicians and no more than 15 non-
physician staff. Children live in every part of the country and, as
such, pediatricians are part of the recovery effort in all communities
after a disaster. When disaster strikes, pediatricians may become
displaced, losing their workplaces and/or their homes. During the
immediate aftermath of a disaster, they may be unable to practice,
leaving children without access to care within their medical home.
Every effort should be made at the Federal, State, and local level to
help pediatricians with assistance relocating or rebuilding within
their communities.
Many clinicians, myself included, are volunteers with the National
Disaster Medical System (NDMS). The NDMS plays a vital role in our
Nation's preparedness but the NDMS and the Volunteer Medical Reserve
Corps (MRC) need more clinicians. Thought should be given to how we
might make it easier on clinicians to volunteer and how we might tailor
pre-certification or training programs to reach clinicians on a broader
scale. Special attention should be paid to the recruitment of
clinicians for specific populations such as geriatrics, pediatrics, and
individuals with disabilities or chronic medical conditions.
Disaster preparedness starts at home with one's own preparedness.
The Academy has provided guidance to pediatricians about preparedness
in their own offices and communities.\11\ For clinicians, there may be
great value in reviewing what type of education, if any, they are
receiving during medical school and subsequent training around disaster
preparedness. A core curriculum around disaster preparedness, including
at-risk population such as children, may be helpful.
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\11\ Markenson D, Reynolds S, Committee on Pediatric Emergency and
Medicine and Task Force on Terrorism. The Pediatrician and Disaster
Preparedness. Pediatrics, Vol. 117, No. 2 February 2006. http://
aappolicy.aappublications.org/cgi/reprint/pediatrics;117/2/e340.pdf.
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hospital preparedness for children
This committee is no doubt familiar with ED overcrowding as a day-
to-day reality for many, if not most, hospitals. Imagine layering on
top of the current situation, a widespread mass care or mass casualty
event involving children. This scenario played out in hospitals across
the country in 2009 during the H1N1 pandemic. Large volumes of patients
and their families sought medical care; pharmacies had to be educated
on how to constitute Oseltamivir for the pediatric populations;
hospitals had to create innovative strategies to address the surge of
patients on top of the baseline patients; physicians and other health
care providers worked to engage their communities and demystify vaccine
safety concerns; physician groups like the AAP partnered with the
government to ensure that media messages were consistent and accurate
with medically sound and timely information. While children were
disproportionately affected by this strain of influenza virus,
fortunately the overall morbidity of this strain was less than
expected.
The experience of H1N1 taught us many lessons. Among them is the
fact that the science of ED surge remains relatively undeveloped.\12\
In a 2008 survey of hospital preparedness by the Centers for Disease
Control and Prevention (CDC), less than one-third (32.4 percent) of
hospitals had guidelines for increasing pediatric surge capacity. About
one-third (34 percent) of hospitals had plans for reunification of
children with families, and only 42.6 percent of hospitals had a
tracking system for accompanied and unaccompanied children.\13\
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\12\ Nager AL, Khanna K. Emergency department surge: models and
practical implications. J Trauma. 2009;67(2 Suppl):S96-99.
\13\ Niska R and Shimizu I. Hospital Preparedness for Emergency
Response: United States, 2008. National Health Statistics Reports, No.
37, March 24, 2011.
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In the face of a disaster, all hospitals will need to increase
their capacity. The vital clinical ability to recognize and respond to
the needs of an ill or injured child must be present at all levels of
care--from the pre-hospital setting, to emergency department care, to
definitive inpatient medical and surgical care. The outcome for the
most severely ill or injured children, and for the rapidly growing
number of special needs children with chronic medical conditions, is
optimized in centers that offer pediatric critical care and trauma
services as well as pediatric medical and surgical subspecialty care.
As it is not feasible to provide this level of expertise in all
hospital settings, existing emergency and trauma care systems and State
and Federal disaster plans need to address regionalization of pediatric
emergency and critical care within and across State lines, leveraging
inter-facility transport as a means to maximize the outcome of the most
severely ill and injured children.
This committee has helped hospitals make notable progress with
their disaster preparedness upon the creation of the Hospital
Preparedness Program, formerly the National Bioterrorism Hospital
Preparedness Program, under PAHPA. The Assistant Secretary for
Preparedness and Response (ASPR) at the Department of Health and Human
Services recently announced that more than 76 percent of hospitals
participating in the National Hospital Preparedness Program (HPP) met
90 percent or more of all program measures for all-hazards preparedness
in 2009.\14\ Without question, the leadership of the ASPR and the
congressional support through appropriations for the Hospital
Preparedness Program has made our Nation better prepared.
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\14\ http://www.hhs.gov/news/press/2011pres/05/20110505a.html.
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The disparity between the CDC's 2008 data on hospital preparedness
and ASPR's recent announcement is striking. As Congress looks ahead to
the reauthorization of PAHPA and the ASPR develops grant guidance for
the HPP program for fiscal year 2012, attention should be paid to what
criteria hospitals are being asked to meet for children, including
children with special health care needs, through the Hospital
Preparedness Program. A ``Whole Community'' approach to the HPP program
and other grant programs may be very beneficial for children and other
at-risk populations. The AAP commends the HPP program for prioritizing
the ``Needs of At-Risk Populations,'' including children, as one of
four overarching requirements that must be incorporated into the
development and maintenance of all program sub-capabilities but we feel
that specific requirements and performance measures pertaining to
pediatric preparedness in the HPP program are currently lacking and
should be included in the future.
To ensure the needs of children, including children with special
health care needs, are integrated into hospital planning, the AAP
recommends the following:
All hospital emergency departments should stand ready to
care for ill or injured children through the adoption of the AAP's
Joint Guidelines for Care of Children in the Emergency Department.\15\
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\15\ American Academy of Pediatrics, American College of Emergency
Physicians, and Emergency Nurses Association. Joint Policy Statement:
Guidelines for Care in the Emergency Department. Pediatrics, Vol. 124,
No. 4 (2009): 1233-43, http://aappolicy.aappublications.org/cgi/
reprint/pediatrics;124/4/1233.pdf.
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All health care professionals who may treat children
during an emergency should have adequate pediatric disaster clinical
and psychosocial support training and equipment.
The creation of guidelines for addressing pediatric surge
capacity and a formal regionalized pediatric system of care including
written transfer protocols and memoranda of understandings (MOUs) with
other hospitals.
The needs of children should be specifically addressed in
exercises and drills including the National Level Exercise.
The inclusion of a focus on mental and behavioral health
for children in disaster planning activities and the enhancement of
pre-disaster preparedness and just-in-time training in pediatric
disaster mental and behavioral health, including psychological first
aid, and bereavement support.
The creation of tracking systems for accompanied and
unaccompanied children and establishment of plans for reunification of
children with families and protocols to identify and protect displaced
children.
emergency medical services for children
The Academy commends the work of the HELP Committee to reauthorize
the Emergency Medical Services for Children (EMSC) program in the
Patient Protection and Affordable Care Act and urges Congress to fully
fund the EMSC program at its authorized level of $27,562,500 in fiscal
year 2012. It is fitting that this hearing is being held 1 day before
national EMSC Day. The EMSC program has played a crucial role in
driving significant improvements in pediatric emergency care, including
disaster preparedness. Despite a modest appropriation of slightly more
than $20 million, EMSC has managed to effect these changes despite the
lack of pediatric emphasis in other related government programs. EMSC
has funded pediatric emergency care improvement initiatives in every
State, territory and the District of Columbia, as well as national
improvement programs. These include the development of equipment lists
for ambulances, guidelines for hospital emergency preparedness,
pediatric treatment protocols, and handbooks for school nurses and
other providers that would be critical in the event of an emergency.
EMSC supports training for emergency medical technicians and paramedics
who often have little background in caring for children, and has
underwritten the development of vital educational materials and
treatment guidelines. In the 27 years since the program was
established, child injury death rates have dropped by 40 percent.
national commission on children and disasters
Recognizing how far children lagged behind in disaster
preparedness, response, and recovery, Congress, led by this committee,
saw fit to create the National Commission on Children and Disasters in
2008. The Commission produced two reports, the most recent in October
2010, in which it makes comprehensive recommendations aimed at the
Federal Government and policymakers. The Commission also called on the
President to develop and present to Congress a National Strategy on
Children and Disasters. Such a national strategy from the President
would serve as a clarion call to government, the private sector,
communities and families to engage one another in setting and achieving
goals and priorities for children.
Of note to this committee, the Commission recommended that
Congress, HHS, and the Department of Homeland Security/Federal
Emergency Management Agency should ensure availability of and access to
pediatric medical countermeasures at the Federal, State, and local
levels for chemical, biological, radiological, nuclear, and explosive
threats.\16\ The Commission offered several proposals to carry out this
recommendation which include amendments to the Emergency Use
Authorization authority to allow the FDA to authorize pediatric
indications of medical countermeasures for emergency use before an
emergency is known or imminent as well as funding and grant guidance
for the development, acquisition, and stockpiling of medical
countermeasures for children. The Academy strongly supports these
recommendations.
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\16\ National Commission on Children and Disasters. 2010 Report to
the President and Congress. AHRQ Publication No. 10-M037. Rockville,
MD: Agency for Healthcare Research and Quality. October 2010.
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The Commission, through the leadership of its Chair Mark Shriver
and my fellow Commissioners, made great progress within the Federal
agencies to improve our Nation's preparedness for children. The
Commission also raised public awareness of the many gaps that exist for
children. Despite the efforts of many on this committee, the Commission
terminated last month as was required by the authorizing language that
created it. The Academy opposes the termination of the Commission and
urges Congress to move quickly to reconstitute it. It is unacceptable
to us, and it should be to Congress as well, to allow the Commission's
recommendations to simply sit on a shelf and gather dust.
medical products for children
In 1977, AAP experts first published a policy statement saying that
not only was it ethical to study drugs in children, it was unethical
not to. Since that time, the Academy has advocated strongly that
children deserve the same standards of therapeutic evidence as adults.
The first step forward in public policy solutions to the lack of
pediatric drug research came in 1997 when Congress, under this
committee's leadership, passed the Food and Drug Administration
Modernization Act. This law contained the first authorization of
pediatric exclusivity, an incentive to study drugs in children. This
program was reauthorized as the Best Pharmaceuticals for Children Act
(BPCA) in 2002. In 2003, the Pediatric Research Equity Act (PREA), a
requirement for pediatric studies, was passed after the Pediatric Rule
was struck down. Finally in 2007, BPCA and PREA were reauthorized
together, creating an integrated system for pediatric research
incentives and requirements. These vital programs for children will
expire on September 30, 2012 and the AAP looks forward to working with
the committee to reauthorize them.
The uniqueness of pediatric therapeutics has been proven over and
over again by surprising and unexpected results. BPCA and PREA studies
have revealed safety issues, altered dosing, led to new indications,
and have shown some drugs to lack efficacy in children. In total,
nearly 400 drugs have been labeled for children as a result of BPCA and
PREA. These laws have also served as a model for international advances
in pediatric therapeutics, including the development of a parallel
pediatric program used by the European Medicines Agency (EMEA). We can
say unequivocally that BPCA and PREA have dramatically improved
pediatric practice.
There are real opportunities to harness the experience of these
programs and the strong leadership of the Food and Drug Administration
(FDA) with Biomedical Advanced Research and Development Authority
(BARDA) and their industry partners to improve pediatric labeling for
medical countermeasures. There are opportunities for collaborations
with the National Institutes of Health (NIH) as well. Within the last
month, NIH released the 2011 BPCA Priority List of Needs in Pediatric
Therapeutics and among the drugs identified by the NIH are several in
the biodefense arena. The Academy looks forward to working with
Congress to maximize the potential of BPCA and PREA in the medical
countermeasures enterprise.
medical countermeasures for at-risk populations
Progress has been made to improve the availability of pediatric
countermeasures but much more work needs to be done. Most recently,
pediatric labeling was added to pralidoxime for the treatment of nerve
agent poisoning meaning it can now be stockpiled for that indication in
children. However, that labeling took 7 years during which time no new
data was presented. It is hard to understand why it took that long.
Pediatric labeling was the first step. HHS and BARDA need to support
the manufacture and purchase of a child-specific auto-injector so that
pralidoxime can be forward deployed and administered in the field.
In the event of a radioactive release much like we saw in Japan,
children must be administered potassium iodide as quickly as possible,
ideally within 2 hours, and in an appropriate form and dosage to
prevent long-term health effects.\17\ The liquid formulation of
potassium iodide exists and is safe and effective but if Federal and
State Governments do not purchase it to be stockpiled in the event of
radiation exposure and in sufficient quantities to treat all of our
Nation's children, how secure are we really?
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\17\ Committee on Environmental Health. Radiation Disasters and
Children. Pediatrics, Vol. 111, No. 6, June 2003.
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The Academy looks forward to the approval of pediatric labeling for
midazolam to treat nerve gas exposure. Those studies are well underway
at NIH and the Academy hopes that NIH and FDA are closely coordinating
their efforts in order to expedite the approval of pediatric labeling.
additional policy recommendations
The American Academy of Pediatrics has specific recommendations for
all policymakers regarding children and medical countermeasures:
The medical countermeasure enterprise, led by the Federal
Government, should set a goal to achieve parity between adult and child
medical countermeasures developed and included in the Strategic
National Stockpile (SNS) and all other federally funded caches.
PAHPA should be amended to require that the Secretary,
acting through BARDA, prioritize children.
The Federal Government should conduct a comprehensive
review of the contents of the SNS and all other federally funded caches
to assess how many products have pediatric labeling and, for those that
don't, the government should create a plan by which pediatric labeling
can be added.
The Emergency Use Authorization process should be amended
to allow the FDA to authorize pediatric indications of medical
countermeasures for emergency use before an emergency is known or
imminent.
The Federal Government must give guidance to States that
ensures they purchase adequate supplies of countermeasures for
children, especially liquid potassium iodide in States with or near
nuclear facilities. And, there must be accountability for States' plans
for maintenance and distribution of medical countermeasures for
children.
Prepositioning of medical countermeasures is critical. All
prepositioning strategies must include locations where children gather,
e.g., schools, child care facilities, and camps, and they must include
plans for children with special healthcare needs.
Because ``children'' encompass individuals from birth
through adolescence, it is often insufficient to have a single size
device to serve all children. In the case of respiratory masks, for
example, different sizes are needed for infants, young children, and
adolescents. Both individual facilities and the SNS must take this into
account and provide for these needs. Similarly, drugs must be available
in appropriate formulations and dosages for children. Infants cannot be
expected to take pills. Needles must be provided in smaller sizes. In
many cases, dosages for children should be determined not by age but by
weight.
Utilize pediatric subject matter expertise in identifying
gaps, setting priorities, planning, and exercising all-hazard disaster
response capabilities.
Federal agencies such as FDA, BARDA, and NIH must
coordinate their efforts with the goal of prioritizing pediatric
medical countermeasures.
conclusion
The American Academy of Pediatrics thanks the committee for this
opportunity to testify on the important issue of medical and public
health preparedness and response. America's children represent the
future of our Nation, our most precious national resource. Children
must not be an afterthought in disaster planning and medical
countermeasures. The Academy looks forward to working with you to
protect and promote the health and well-being of all children,
especially in emergency and disaster preparedness. We would like to
offer the children and disasters Web site of the Academy as a resource
to you as you work on disaster preparedness issues. It can be found at
www.aap.org/disasters.
Finally, we would like to leave you with the findings of recent
public opinion polling released by the AAP in partnership with
Children's Health Fund on the use of resources related to disaster
planning and response specific to children's issues. The poll found:
76 percent of Americans agree that if resources are
limited, children should be given a higher priority for life-saving
treatments;
75 percent believe that if tough decisions must be made,
life-saving treatments should be provided to children rather than
adults with the same medical condition; and
92 percent agree that if there were a terrorist attack,
our country should have the same medical treatments readily available
for children as are now available for adults.
You represent fathers, mothers, grandparents, uncles and aunts, our
children deserve better. When disaster strikes, we as a nation must be
adequately prepared so that our children will be protected and can
achieve their full potential. As a pediatrician and a father, I look
forward to your questions and to working with you to address the
preparedness needs of all children.
Senator Casey. Thank you, Doctor.
Commissioner Cooper.
STATEMENT OF SUSAN R. COOPER, MSN, RN, COMMISSIONER, TENNESSEE
DEPARTMENT OF HEALTH, NASHVILLE, TN
Ms. Cooper. Thank you. I don't have any family here either
and so I will just say thanks to all the public health folks in
Tennessee who work every day to protect, promote and improve
the health of those that live in, work in and travel through
our great State.
Mr. Chairman and distinguished committee members, it is
truly a special privilege today to be before you to discuss an
issue of such great importance to our Nation, public health and
medical preparedness and response. The thoughts I will share
with you today are my own, but they are shared with so many
public health professionals at the State and local levels
across this country who devote considerable time, attention and
resources preparing to most effectively manage the consequences
of an array of emerging and evolving threats such as disease
outbreaks and disasters in order to prevent or reduce illness,
injury and death.
You know, as we sit here today we are just 4 months away
from the 10th anniversary of the attacks of September 11th,
which were followed 1 month later by the anthrax attacks. These
two acts of terrorism were seminal events that made it evident
to all Americans and all Tennesseans of the dangers that we can
expect to face. By everyone's account here there is no question
that tremendous progress has been made over the past 10 years.
We are much better prepared now than we were on that memorable
Tuesday morning.
You have heard of several reports that are out. The Centers
for Disease Control and Prevention in September 2010 reported
that they reviewed preparedness activities of the States and
territories and in our four largest cities. And they concluded
that much progress has been made to build and strengthen
national public health preparedness and response capabilities.
This report provided that a national snapshot that shows that
all States have reporting capacity systems that can receive
urgent disease reports at any time of the day or night, 7 days
a week. They have capabilities to receive, distribute and
dispense strategic national stockpile assets and nearly all
States can rapidly respond within 30 minutes to a health alert
network message, which provides information to State and local
public health practitioners, clinicians and public health labs
about urgent health events.
We know that every State has developed and continues to
refine the pandemic planning as required by PAHPA. The Trust
for America's Health Annual Ready or Not Report acknowledges
again that the country has made great strides. It showed that
last year all but one State has increased or maintained its lab
response network.
One more illustration. Just last month, released from ASPR,
was the report that talked about hospital preparedness. And we
can show now what the numerous ways, including planning for all
hazards, increasing search capacity and tracking the
availability of beds and other resources and developing
communication systems that are interoperable with partners.
We still have work to do, though. It is really great to see
how well we are doing in writing, from all these respected
authorities, but I am where the rubber hits the road and I am
here to tell you that the progress is palpable but this system
is fragile and it is the point that I will come back to in just
a few moments.
Our decade-long commitment in investing and strengthening
the Nation's public health enterprise has and continues to pay
off. But we see, every single day, examples where these systems
are being put into practice. If you just look back over the
past year, there is no doubt in my mind that my colleagues in
Alabama and Louisiana who have faced disasters with the Gulf
oil spill, you think about the flooding in North Dakota, you
think about the effects of the tsunami in Hawaii and Washington
State and Oregon and then you think about my State of Tennessee
who has just suffered through the super cell tornados, terrible
devastation in many of our rural counties and significant
flooding in Memphis. We have signs of the emergency
preparedness system working well every single day. When we look
at preparedness though, we need to consider that public health
preparedness is not an endpoint it is a process and it cannot
remain static. We have to continuously rigorously review what
we are doing and revise our State plans.
One additional point is the critical importance role that
our partners play. When you look at our experience with H1N1
and our ability to work with retail pharmacies across our
State, this added to our public health response capacity and I
think we need to take a stronger look in that direction as
well.
I want to conclude with just a few points. First of all, I
think there is a need to reauthorize PAHPA with a few minor
adjustments. Second, is that we face very difficult times and
hard budget decisions must be made. But when it comes to our
preparedness programs I will tell you in Tennessee alone our
base preparedness funding has decreased by 37 percent from 2004
to 2011 with an additional cut in just an announcement that
came out. Our Nation's State and local public health system is
seriously frayed. We have seen budget cuts at all levels of
government that have resulted in more than 44,000 State and
local public health jobs, staffs, FTEs, going away. These job
losses represent 14 percent of State health workforce and 20
percent of local health workforce. In the midst of a crisis is
not the time to find your staff. You have to be prepared to
respond.
The last point is about community resilience. One of the
best ways to help a community become more resilient is to
improve their overall health. No State or community is ever
completely prepared to address the health and medical
consequences of a major disaster, terrorist event or pandemic.
We have improved since 2001 but we still have a way to go.
If you think about the reports I cited earlier that
demonstrated progress, they also identified that more needs to
be done. Protecting the public from threats is a matter of
national security and protecting the public's health is no
exception.
Thank you. We will be happy to answer any questions.
[The prepared statement of Ms. Cooper follows:]
Prepared Statement of Susan R. Cooper, MSN, RN
Preparedness Approach--Our approach to preparedness follows two
main principles:
(1) build capacity and capabilities that can effectively address
all hazards, both for everyday emergencies, as well as for catastrophic
events; and
(2) preparedness is not an end point, it's a process that must
continually be developed, maintained, refined, and improved.
Capabilities--While the birth of our modern day preparedness and
response efforts was appropriately centered on bioterrorism, we quickly
learned that the most effective and efficient way to protect the public
was to know all of your vulnerabilities, anticipate those threats, and
build systems, programs, and services that are flexible and agile
enough to handle anything that may come our way. Building and
maintaining capabilities in such areas as: (1) incident management; (2)
information sharing and public warning; (3) biosurveillance
(epidemiology and laboratory services); (4) countermeasures
distribution and dispensing; (5) surge management for mass health care
delivery, mass fatalities, and the coordination of volunteers; and (6)
community resilience are in so many ways universal in their application
to any and all hazards.
Disaster Threats--Emergencies and disasters impact the health of
Americans every day. Public health responds to all hazards, be it a
disease outbreak, a pandemic, the health consequences of natural
disasters, or a man-made incident, like a terrorist attack. And these
events happen in big cities, rural and suburban communities, and in
every State. Not only last year at this time, but even as we speak
today, in Tennessee, we have and are experiencing episodes of severe
weather and flooding (2010/2011). Even as this is occurring, we must
concurrently plan for the continuing threat of a New Madrid Seismic
Zone earthquake and the catastrophic impact it would have on the State.
Other threats that have manifested in emergency response include: white
powder incidents (ongoing since 2002), sheltering of hurricane evacuees
from partner States (2005/2008), TVA coal fly ash spill (2008), ice
storms (2009), and the H1N1 influenza pandemic (2009). As each unique
disaster is evaluated for areas of improvement, the lessons learned are
carried forward to improve future response efforts.
Priorities--Engagement with partners, effective communications, and
building community resilience are at the heart of every public health
agency's goals in emergency preparedness and response. In Tennessee,
we've focused on these priorities as follows:
(1) Partner collaboration--Community partners from healthcare (H1N1
retail pharmacy), business, media, State and local governmental
agencies and bordering States have all been at the table to contribute
to planning and response efforts. This is especially valuable as we
continually strive to improve our medical countermeasures distribution
and administration operations.
(2) Information Sharing and Situational Awareness--With the
assistance of preparedness funding, the Tennessee Emergency Medical,
Awareness, Response, and Resources suite of information systems has
been developed and includes the Hospital Resource Tracking System,
Tennessee Health Alert Network, Tennessee Volunteer Mobilizer, and the
Tennessee Countermeasure Response Network. We also established Regional
Medical Communication Centers to improve interoperable communications
among EMS agencies, emergency management, hospitals, and public health
to support a medical response. Interoperability initiatives are
paramount to the success of data exchange between response partners.
(3) Community resilience--To ensure comprehensive community
resilience and preparedness, Tennessee has adopted an all-hazard
planning approach. This approach must include prevention strategies
that are innovative and aggressively outreach to multiple population
groups. Some of these initiatives include the annually high rates of
childhood immunizations, collaborations with mental health providers
for disaster response, child care center preparedness planning,
vulnerable population outreach and information sharing, ongoing
dialogue with professional associations, and a proactive training and
exercises.
______
Chairman Harkin, Ranking Member Enzi, and distinguished committee
members, it is my special privilege to appear before you today to
discuss an issue of great importance to our Nation, public health and
medical preparedness and response. The thoughts I will be sharing with
you today, while my own, are also embraced by my many State and local
public health colleagues across the country that devote considerable
time, attention, and resources preparing to most effectively manage the
consequences of an array of emerging and evolving threats, such as
disease outbreaks and disasters, in order to prevent or reduce illness,
injury, and death. In the few minutes I have for opening remarks, I
would like to talk about how far we have come and what more we must do
to maintain our state of readiness.
We sit here today just 4 months away from the 10th anniversary of
the attacks of September 11, which were followed just 1 month later by
the anthrax attacks. These two acts of terrorism were seminal events
that made it very evident to all Americans of the dangers we can expect
to face in the future and the need to rapidly escalate our bioterrorism
preparedness efforts that began in earnest just 2 years earlier in
1999.
By everyone's account, there is no question that tremendous
progress has been made over the last 10 years. We are so much better
prepared now than we were on that memorable sunny Tuesday morning in
mid-September 2001.
In the Centers for Disease Control and Prevention (CDC) September
2010 report where they reviewed the preparedness activities of the
States, territories, and the four largest U.S. cities, CDC concluded
that, ``much progress has been made to build and strengthen national
public health preparedness and response capabilities.'' This report
provides a national snapshot that shows that all States have a
reporting capacity system that can receive urgent disease reports at
any time of the day, seven days a week; have capabilities to receive,
distribute, and dispense Strategic National Stockpile assets; and
nearly all States can rapidly respond within 30 minutes to Health Alert
Network messages, which provide information to State and local public
health practitioners, clinicians, and public health laboratories about
urgent health events. We also know that every State has developed and
continues to refine its pandemic planning, as required by the Pandemic
and All Hazards Preparedness Act (PAHPA).
The Trust for America's Health annual Ready or Not Report in
December 2010 acknowledges that, ``over the past decade, the country
has made great strides in preparing for public health emergencies.''
This report shows that last year all but one State increased or
maintained its Laboratory Response Network capability for chemical
threats and 43 States and DC can currently send and receive important
electronic health information with health care providers in their
jurisdiction.
One more illustration, just last month, in April 2011, the HHS
Office of the Assistant Secretary for Preparedness and Response (ASPR)
reported that we have advanced the preparedness of hospitals and
communities in numerous ways, including through planning for all-
hazards, increasing surge capacity, tracking the availability of beds
and other resources using electronic systems, and developing
communication systems that are interoperable with other response
partners. We can now also work with greater speed and improved response
time since so often time is of the essence when it comes to information
sharing, laboratory detection of biological threats, and getting
vaccines and antibiotics to the public who may be in harm's way.
While it is great to see this in writing from respected
authorities, for those of us on the job and in the communities doing
this work, this progress is very palpable, but yet fragile, a point I
will come back to in a few moments.
Our decade-long commitment of investing in and strengthening the
Nation's public health enterprise has and continues to pay off in so
many ways. Congress, and especially this committee, should be applauded
for its work on laws like PAHPA that give States, territories,
localities, and tribes the resources and tools needed to get the job
done.
Our approach to preparedness follows two main principles: (1) build
capacity and capabilities that can effectively address all hazards,
both for everyday emergencies, as well as for catastrophic events, and
(2) preparedness is not an end point, it's a process that must
continually be developed, maintained, refined, and improved. Allow me
to elaborate.
While the birth of our modern day preparedness and response efforts
was appropriately centered on bioterrorism, we quickly learned that the
most effective and efficient way to protect the public was to know all
of your vulnerabilities, anticipate those threats, and build systems,
programs, and services that are flexible and agile enough to handle
anything that may come our way. Building and maintaining capabilities
in such areas as: (1) incident management; (2) information sharing and
public warning; (3) biosurveillance (epidemiology and laboratory
services); (4) countermeasures distribution and dispensing; (5) surge
management for mass health care delivery, mass fatalities, and the
coordination of volunteers; and (6) community resilience are in so many
ways universal in their application to any and all hazards.
Just thinking back over the last year, there is no doubt in my mind
that my colleagues--like Don Williamson, the State health officer in
Alabama, and Jimmy Guidry, the medical director and State health
officer in Louisiana, in their handling of the Gulf Coast Deepwater
Horizon Oil Rig Disaster; or Terry Dwelle, the State health officer in
North Dakota, dealing with the flooding of the Red River; or Loretta
Fuddy, the director of health in Hawaii, and Mary Selecky, the
secretary of health in Washington State, as they work hand in glove
with their emergency management and environmental protection
counterparts on the Japanese Earthquake/Tsunami and nuclear reactor
radiation release crisis--they all will tell you that the strength and
success of their response can be directly attributed to years of
planning and preparedness following an all hazards model. Even as we
sit here today, there are multiple States still recovering from the
severe weather of late April/early May that included severe super-cell
tornado outbreaks and repeated rounds of severe rain that have now
resulted in raging flood waters in the Mississippi River valley.
And in my State of Tennessee, we live in the New Madrid Seismic
Zone, which includes the States of Tennessee, Kentucky, Missouri,
Arkansas, and Illinois. The planning assumptions for a catastrophic
earthquake of a magnitude seven or greater in this area could impact 50
percent of Tennessee's population. Such an earthquake would overload
response capabilities and cripple local and State government. Tennessee
projections include: 33,000 injuries, 3,000 fatalities and 7,000
seriously injured; 342,000 in need of shelter; 2.1 million without
food, water, or ice; 107,000 structures totally destroyed; 265,000
structures with major damage; 1,000 damaged bridges, 330 collapsed; 608
schools collapsed and unusable; 54 hospitals damaged; and 50 percent of
all emergency vehicles destroyed. Up to seven other States may
experience similar levels of loss of life, damage and destruction.
We have been engaged in a wide array of public health emergency
responses including multiple white powder incidents (ongoing since
2002), sheltering of hurricane evacuees from partner States (2005/
2008), TVA coal fly ash spill (2008), ice storm (2009), and the H1N1
influenza pandemic (2009). More recently, the response activities
associated with the severe flooding in both May of 2010 and 2011
included shelter staffing and support, vaccinations, water sampling,
community assessments, vector control, prescription assistance, the use
of emergency response information systems, and the creation of public
information messages and fact sheets that were posted to the State's
Web site and disseminated to the public and response partners. Of note,
our previous work in 2010 was leveraged during our 2011 flood response
allowing us to be ready, agile, and fully engaged. As a result of
planning, exercising, frequent communications, and improvements in
community health, Tennesseans responded to assist their neighbors and
their communities. The results of these efforts represented a visual
picture of the successes of the preparedness interventions. The
successful public health response and recovery was made possible by
preparedness funding.
Regarding my second point about preparedness being a process, not
an end point, the main thought here is that plans cannot remain static,
they must be periodically and rigorously reviewed and revised based on
experience, lessons learned, and evolving information; sophisticated
laboratory and field equipment must be properly maintained and
serviced; the public health workforce must remain sharp and skilled
requiring ongoing training; and our plans and people must go through
regular drills and exercises to reinforce our strengths and identify
gaps and weaknesses where we need to improve on a continuous basis.
This takes not only ongoing commitment, but resources.
Before I share with you my final thoughts, one additional point I
want to make is the critical importance and value of partner
collaboration, information sharing and situational awareness, and
community resilience. In Tennessee, community partners from healthcare,
business, media, State and local governmental agencies and bordering
States have all been at the table to contribute to planning and
response efforts. One example includes the partnership with retail
pharmacies and their ability to participate in both the H1N1
vaccination campaign and antiviral medication distribution to the
under-insured. These partners equate to public health force multipliers
and can have a significant impact on prevention of disease. These
relationships will continue to be fostered to ensure all-hazards
response capabilities exist. This is especially valuable as we
continually strive to improve our medical countermeasures distribution
and administration operations.
With the assistance of preparedness funding, the Tennessee
Emergency Medical, Awareness, Response, and Resources (TEMARR) suite of
information systems has been developed. TEMARR integrates numerous
systems, technologies, programs, and leadership from across the State
to respond to emergencies. Collectively, the TEMARR systems provide a
broad picture of situational awareness and are used to more effectively
manage and monitor Tennessee Department of Health (TDH) responses to
disasters using national and international data exchange standards. We
now have the capacity to better understand the disaster itself, alert
key response agencies, identify and contact pre-credentialed first
responders, allocate resource needs in terms of people and equipment,
apply all required resources to the disaster, quickly triage and track
all persons impacted, and transport them to the correct healthcare
facility. Using ASPR funds, the State established eight Regional
Medical Communication Centers as a joint venture between hospitals and
TDH. Prior to the centers, limited interoperable communications existed
among EMS agencies, emergency management, hospitals, and public health
across the State to support a medical response.
The above information systems could not have been developed without
preparedness funding and will quickly disappear without sustained
funding. By developing and delivering the TEMARR systems to the State
we eliminated the need for multiple agencies to construct or procure
like capabilities. The use of statewide solutions, that meet the needs
of system users, provides for the sustainability of information
technology infrastructure. The innovative use of interoperability
standards supported by the U.S. Department of Homeland Security Office
of Interoperability and Compatibility has promoted data exchange and
collaboration at the Federal, State, and local level. Other critically
needed efforts beyond pure requirements and standards development are
to continue collaboration with the HHS Office of the National
Coordinator (ONC) for Health Information Technology and ASPR, and to
merge, integrate or support the transparent movement of message traffic
across health information exchanges.
To ensure comprehensive community resilience and preparedness,
Tennessee has adopted an all-hazard planning approach. This approach
must include prevention strategies that are innovative and aggressively
outreach to multiple population groups. Some of these initiatives
include the annually high rates of childhood immunizations,
collaborations with mental health providers for disaster response,
child care center preparedness planning, vulnerable population outreach
and information sharing, ongoing dialogue with professional
associations, and proactive training and exercises.
As we look toward the future, with your permission, I would like to
respectfully share with you three recommendations for your
consideration:
First is the need to reauthorize PAHPA. The Pandemic and
All Hazards Preparedness Act is a well-designed and effective law that
served us well. That being said, over the 5 years of it being in
existence and in working with and using PAHPA, a short list of
potential revisions and additions have been identified that would make
a reauthorized PAHPA even stronger and more effective. I know your
staff have been in contact with ASTHO leadership and discussed our
suggestions for consideration.
Next, even during these very difficult fiscal times when
hard budget decisions have to be made, adequate funding through the CDC
Public Health Emergency Preparedness (PHEP) and ASPR Hospital
Preparedness Program (HPP) cooperative agreements to States must be
maintained. We cannot let our progress erode. Tennessee-base
preparedness funding has decreased by 37 percent from 2004 to 2011.
The Nation's State and local public health system is already
seriously frayed due to the adverse impact of the recession on State
and local governments. Budget cuts at all levels of government are
jeopardizing the significant gains that State, territorial, and local
health departments made in prevention and preparedness programs during
the past decade. From 2008-10, more than 44,000 jobs were lost in State
and local health departments, reducing staff such as public health
physicians and nurses, laboratory specialists, and epidemiologists.
These job losses represent 14 percent of the State health workforce and
20 percent of the local health workforce. Recent reports from both the
Association of State and Territorial Health Officials (ASTHO) and the
National Association of County and City Health Officials (NACCHO), on
the impact of budget cuts on the health of Americans indicate that,
since 2008, State and local health agencies have been forced to reduce
critical public health programs, such as immunizations, HIV/AIDS
prevention and treatment activities, and all-hazards preparedness and
response efforts.
My last point is that of community resilience. One of the
best ways to help a community become more resilient is to improve their
overall health through prevention. A healthier community and a
healthier individual will fare far better in an emergency than a
community or individual that is coping with underlying preventable
health conditions, such as obesity, heart disease, or diabetes.
Ensuring that adequate resources and attention is paid to addressing
America's major health problems and common risk factors will have a
major impact on the overall preparedness and response capacity of
public health, and all other, emergency responders. These can be
addressed through other Public Health Service Act programs authorized
by this committee, such as the Prevention and Public Health Fund,
Community Transformation Grants, and the Preventive Health and Health
Services Block Grant, just to name a few.
No State or community is ever completely prepared to address the
health and medical consequences of a major disaster, terrorist event,
or pandemic. However, since 2001, States have significantly improved
and demonstrated their ability to prevent, respond to, recover from,
and reduce the effects of a full range of threats and hazards. Through
planning, training, education, drills, exercises, and building
partnerships, State public health agencies have improved disease
surveillance and laboratory testing, patient care surge capacity,
decontamination capacity, and availability and deployment of
pharmaceutical and other medical supplies. If you recall the reports I
cited earlier that demonstrated progress, they also identify more that
needs to be done, which requires our collective attention. Protecting
the public from threats is a matter of national security, and
protecting the public's health is no exception.
Thank you for this opportunity and I would gladly address any of
your questions.
Senator Casey. Commissioner, thank you. And thanks for
reminding us of some of the challenges people are experiencing
right now, horrific tragedies.
Dr. Anderson, I wanted to start with you with regard to
children. And I know you spoke to this in your statement. I
wanted to turn to your prepared statement and ask you to
amplify or maybe reiterate some of what you said. You say, and
I'm looking at page 5 and page 6, you say in that third
paragraph under the general heading, ``Hospital Preparedness
for Children'': ``In the face of a disaster all hospitals will
need to increase their capacity.'' And then you go on to talk
about pre-hospital setting, emergency, surgical.
Then on page 7 you say, in the second full paragraph,
``As Congress looks ahead to the reauthorization of
PAHPA and the ASPR develops grant guidance for the HPP
program for this fiscal year coming up, attention
should be paid to what criteria hospitals are being
asked to meet for children, including children with
special healthcare needs.''
And it goes on from there. And you referred to some
recommendations that the Academy has. Can you go through those
and highlight--I am not saying you have to go through all of
them, it is in your testimony, but just highlight why you are
making those recommendations.
Dr. Anderson. Excellent question, Senator. What we look to
at the American Academy of Pediatrics and the world of
children's hospitals is really helping non-children's hospitals
prepare for the needs of kids. And it really starts with day-in
and day-out preparedness. We are talking about big disasters,
mass casualty events--hospitals that aren't used to seeing a
lot of kids have to be prepared every day, because parents are
going to see emergency room and think, OK, I now have my child
at a place that is going to give wonderful care. We need to
assure that as best we can.
The AAP has put out several statements. Here is the stuff
you need, and it starts with equipment because the equipment
for children is very, very different. Here is the training you
need, there are wonderful courses if you don't take care of
kids a lot, to sort of dust off the memory. And by the way, one
of the most important recommendations are to have a coordinator
at each and every hospital in this country, each and every ER
that is that pediatric person, that is always that sort of
annoying, clanging person. Have we thought about the kids? Do
we have the right stuff? Hey, beautiful new decontamination
chamber. How are you going to do kids? How are you going to
decontaminate kids in wheelchairs? So we have to start from a
day-in and day-out preparedness and then figure out when the
big one hits how are we going to surge up.
Several of my co-panelists and Dr. Lurie mentioned we
learned a lot of lessons from H1N1. We were reaching out to
community hospitals in northeast Ohio saying,
``If this gets really big and our children's
hospitals are closed or only taking the sickest of the
sick, are you prepared, community hospital, to keep
kids overnight, to admit children, when you haven't
done that in 20 years?''
We also have some recommendations, if we hit that sort of
surge capacity, how do you reach out and find physicians to
come help you staff it. How do you find the right equipment?
How do you work with your local children's hospital in a
regionalized approach to sort of figure out what children need
the children's hospital and what kids could stay locally.
So, to make a long story as short as I can, it starts with
day-in and day-out preparedness. Are you ready for what we call
``the disaster of one,'' that really sick kid you are not used
to taking care of and then how do you ramp up if you've got
more and more of those kids.
Senator Casey. How prepared do you think we are just as it
relates to this particular issue? Hospitals preparing for
treating children and caring for children in the aftermath of a
disaster?
Dr. Anderson. As a practicing ICU or PICU doctor, I think
we are better prepared than we have been. There were some very
disconcerting studies in the early 2000's that showed only 6
percent, repeat 6 percent, of ERs had the right equipment. I
think that number is a lot better now. I think we are seeing
people really take these recommendations seriously.
I think unfortunately we are learning lessons from Katrina,
from tornados, etc. But I still think there is a lot of work to
be done. It is important to celebrate our successes but it is
much more important to advocate for getting better prepared.
Senator Casey. And based upon your experience and based
upon your interfacing with folks who are the real world of
running hospitals and delivering healthcare, often when someone
in that real world hears government say the following words,
``thou shalt'' and then gives the directive that folks running
a hospital or running a business say, ``that is easy for you to
say, let me tell you the impediments to compliance.'' What do
you hear in terms of hospitals saying, ``we would love to do
all this but we can't?'' Is it mostly access to capital?
Or is it something more significant?
Dr. Anderson. It is a great question, because we have heard
some push back. It is another unfunded mandate. I have to come
up with this list of stuff and this list of--we are not asking
for a $2 million suite off of your ER that has all the latest
technology. The basics are the basics, and that is training,
very readily available courses, the basics of equipment. The
basics, if you are going to have a drill, which disaster drills
are part of Joint Commission accreditation, why not include
kids? The chances are 22 percent of our population are
children, why not just include them in the drill.
We do occasionally hear, as advocates for kids, a little
push back, this is another unfunded mandate, but we are not
asking for big stuff here. This is a coordinator, equipment,
training and drills and I think that is pretty straightforward,
quite frankly.
Senator Casey. I will come back to some of our others, but
Senator Burr.
Senator Burr. Thank you, Mr. Chairman. I had high hopes
that when the average age on the dais today got below 60 the
air conditioning would come back on and it would get cooler in
here.
[Laughter.]
I think we are making progress, but it is a slow process.
Let me also just make a comment and I will be as diplomatic
as I can. I always find it amazing that we could be at a point
in time talking about the reauthorization of PAHPA, the
importance of it and that the key individuals that work within
the framework of it, who came here to testify didn't find it
interesting enough to stay and listen to the second panel where
we talked about how it is working within BIO, within hospitals,
within the community health network and from somebody who was
one of the most instrumental architects of the original bill.
I say that to the whole cadre of HHS folks and I hope
whoever was assigned the responsibility to stay in the room and
take notes, that you take pretty darn good ones, because I find
it appalling that those officials who ask to serve in this
capacity and carry this out don't find any significance in
staying and hearing what this panel has to say, but more
importantly, what the questions are of the members for the
second panel.
With that, Commissioner Cooper, let me just ask you. What
do you see as the key challenges for the public health
departments regarding bio-surveillance and the capacity to
detect novel and unknown viruses?
Ms. Cooper. It is a great question. There are several
challenges. One is just the technology to do so. It would be
nice to be able to pull up a screen on a computer, any given
day, and be able to track any outbreak in any hospital or any
physician's office in our State. We can't do that right now.
The second thing is workforce capacity is a struggle for
us. If you look at the challenges we face, I talked a little
bit about the number of folks that have gotten out of the
public health field, if you just look at my health department,
our State health department, by December 2012, 42 percent of
the State public health workforce is eligible for retirement.
And when you look at those jobs that have been eliminated you
are talking about public health physicians, nurses,
epidemiologists, laboratorians, that is a workforce that needs
to be replenished. And we have significant challenges in
drawing people into the field of public health.
Also, we have had great support from our Federal partners
along the way, but as Admiral Lurie said, there is much more to
be done. We need some real-time detection devices that can give
an isolate right where you find it, whether it is in a
community, in a hospital instead of having to vet it through
multiple laboratories.
Senator Burr. I am sure I am not telling you anything that
you don't know, but if today the CDC were to provide access--if
they contracted with one of a couple of companies that monitor
prescriptions that were written yesterday, and they allowed
local health departments access to that, you could look by zip
code all the way down to the four digit additional, meaning you
could detect, almost in a city block, individuals who had seen
different doctors or gone to different hospitals and were
treated for similar things, cluing you in to a problem. We
don't, today, make that available.
It is not a technological breakthrough, this is something
that is at our fingertips today where right and left hands
don't understand the capabilities that we can provide in real-
time, in a 24-hour period we could know, regardless of where in
Tennessee, there had been exposure to anthrax because of what
was determined from a diagnostic standpoint, what was
prescribed from a pharmaceutical standpoint and you could start
looking at, did this happen at the workplace or did it happen
at the home based upon what those area codes or zip codes in
fact told us.
I am going to run out of time. I want to go to Dr. Bob real
quick and just say, are we prepared? And if not, what do we
need to do?
Dr. Kadlec. Sir, I will go back to an occasion on June 30,
2008 when I told the last president, after 8 years and $50
billion, that we weren't prepared for a modest-size anthrax
attack. And basically said, the difficulty we have, is that
when you look end to end we have some of the pieces in place,
but not all the pieces in place. So if you look at that one
particular problem alone, you raise the issue of detection, we
have some capabilities in that space, but still we don't have
point-of-care diagnostics for clinicians to be able to rapidly
make that diagnosis in any major metropolitan emergency room.
Along the chain of that we have 60 million 60-day courses of
antibiotics and we have no guarantee that we can get them to
the people who need them when they need them. That the
distribution mechanisms we have in place may be too slow to
deal with the kind of event that we would anticipate in that
way. In some ways we lack a little bit of imagination of how to
address that problem. In many ways, some of the challenges
there are logistics.
The third one is, we just have to basically make a
commitment to do this. We have a stockpile of anthrax vaccine
that quite frankly sits in a nice cool place and at some point
in time will expire and will be thrown away. And yet we could
basically use that material today and have volunteers, first
responders, members of the National Guard, members of different
first responder communities basically use that product.
And the last one is, then why don't we have antibiotics if
people want to store them in their home and there is a way to
do this responsibly so to prevent abuse, potentially avoid
antibiotic resistance in populations to basically develop these
med kits? Again, an FDA issue that could be readily done.
So there are a variety of things that could be done along
this whole chain, but quite frankly we haven't just made a
commitment to get it done. And so in some ways we study the
problem to death, but we just don't act on the things that we
know that we could do to effectively change that equation
today.
Senator Burr. I thank you for that and hope that all of you
will make yourselves available for additional questions from me
and from all the members. But more importantly, if there are
details that you have, as we go through the reauthorization,
that you will share those ideas with us no matter how around
the edges they might be. It is important that we try to
incorporate it.
I had a conversation several weeks ago with somebody that
had inquired about the BARDA process and a particular
countermeasure for a known threat. And as I understand it, the
response they got was, ``well that is not an imminent threat,
therefore that is sort of on the back burner.'' When this was
created we didn't ask DHS to list whether threats were
imminent, we just asked them to list if they were real.
I think it was our belief, that if that could happen, then
we need to be prepared. None of us have the foresight to know
who or when somebody might use it or whether Mother Nature
herself will present us a curve ball. That is one of the
reasons that we set it up the way we did where another agency
establishes that threat and, from within HHS, their mission is
to bring a countermeasure or a vaccine to the stockpile or
capabilities of having it to offset it. We never envisioned
that there were threats that were not imminent. They are all
imminent if in fact they fall into the category that we have
resolved.
So I thank all of you and I look forward to working with my
colleagues on this panel. I believe that reauthorization is
absolutely essential. I think we can do it better than we did
it before. It will not be easy and we will have some push back
from people within the government simply because we are going
to have to challenge the culture that is out there right now.
I thank the Chair.
Senator Casey. Thank you, Senator Burr and thanks for your
work on these issues.
I want to move to Senator Whitehouse.
Senator Whitehouse. Thank you, Mr. Chairman. It has been a
very good hearing so I haven't been patient at all, I have been
very interested and I appreciate that the witnesses have come
here and shared their expertise with us.
Dr. Kadlec, could you evaluate for me the--I don't--they
are not exactly different strategies, but they are sort of more
like opposite ends of the spectrum on strategy. One is prepare
in advance, build your medical countermeasures in advance,
stockpile them in vast numbers and develop a rapid development
and deployment strategy so that when something, to use Senator
Burr's description, a curve ball comes down the road that you
haven't stockpiled for, you are in a place where you can move
rapidly to protect the public health in that circumstance.
And if it is appropriate, if you could distinguish between
the two strategies or the two ends of the spectrum strategy in
the light of known threats, like flu and anthrax versus the
unknowns that might be coming at us or the modified biologics
that might be coming at us.
Dr. Kadlec. The best way to look at it, is as book ends. So
if you had to look at a book end of the policy and capabilities
that were developed for smallpox, for example, it was a clear
policy decision to basically take smallpox off the table, for
which we basically procured or had in our possession 300
million doses of the smallpox vaccine. And we are looking now
to basically expand that stockpile by ensuring that
particularly for people with compromised immune systems that
you could have a product that wouldn't be harmful to them if
you had to prospectively immunize them in advance of a threat,
credible threat, or if there were an outbreak that you could
reasonably protect them to ensure that the vaccine itself
wouldn't harm them. So that is one end of it.
The other end of it is, this idea of stockpiling 300
million. In between, is their 12 other potential agents of
concern that we have. If you look at the list, for me anthrax
on down through rickettsia or typhus. The point is we haven't
made the same determination what we would need there. So in
some cases we have looked at anthrax and basically said,
``well, we need 80 million doses,'' 75 million doses in the
stockpile, but we haven't made the affirmative decision, well
what would happen if it would be used against us, do we want to
immunize everyone in the United States? What is our ability to
do that? So there's the flexibility within the known.
Then there is the issue of the unknown, as you say. And
what I am concerned about is basically the idea that if you
basically take this as a one off of pandemic influenza, which
in some ways I think is the strategic choice to date, that you
would somehow use a variety of different platforms to make a
pandemic influenza vaccine, well that may be appropriate. You
need 600 million, theoretically, for the whole country. The
question is, what happens if you are attacked by multiple
biological agents.
And maybe only one platform is capable of doing that.
So one of the things that I think is necessary in
evaluating this is a little bit of, if you will red team it,
also evaluating the platforms that you have to maximize that
your depth, your capacities that are available go beyond what
just exists maybe in one or two facilities, but really would be
able to mobilize what is in the private sector.
Also looking for the technology innovations, and I think
there has been some work in that space, to see what may be out
there. Again, not FDA approved yet, but something that may be a
decade away to do so, but yet could be leveraged in this case
as well.
So the answer is, there is no clear strategy. There are
some strategic options that are out there. We have made some
partial decisions but we haven't, what I would say, made a
holistic, comprehensive one, which I think is kind of the worse
place of all to be.
Senator Whitehouse. With respect to my questions earlier
about the state of our capability for developing rapid response
in the event of an attack using unknown biological agent and
the BARDA process that is our sort of first venture into
developing that capability, how are we doing?
Dr. Kadlec. I think one of the things, and the name was
supposed to give it away, a kind of BARDA sounded like DARPA.
Again, it was Senator Burr's concept. But, really it was to
provoke the notion that somehow we would give all the
authorities, as DARPA has, other transactional authorities, to
really give it the maximum flexibility to basically engage to
look for innovative technologies and rapidly bring and
accelerate development of these products as we need to, whether
it be platform technologies or specific countermeasures.
Senator Whitehouse. Is it working?
Dr. Kadlec. It hasn't quite--it hasn't worked that way. I
think part of it has been a resource issue. I alluded to
earlier, if you only give them 40 percent of the budget that
they theoretically need or they have identified they needed,
you have to wonder whether they can effectively do their
mission.
But I think part of it is, again pushing the envelope as to
what you are willing to do. And it is a very difficult thing to
suggest, particularly given all the regulatory issues around
it. And now I think one of the vital pieces that have been laid
on the table by a number of people is this idea of improving
regulatory support, bringing the FDA into the tent and having
them more as an active participant in this thing can alleviate
some of the challenges.
But quite frankly, I think it does take a bigger push, and
again, a bit of imagination to say, ``how can we do this
better, faster.'' Originally we even said a bit cheaper if you
could, to basically work in a program that was competitive in
nature, that you would highlight a number of potential
candidates, bring them down the pipeline, making critical
decisions, as a pharmaceutical company would do, to basically
identify which, at the end, is the investment that you have to
put your money on to basically ensure you have an FDA licensed
product.
But I don't think it is where we need to be. Part of it is
I think some of it is authority, part of it is the regulatory
involvement and part of it is a resource issue.
Senator Whitehouse. Thank you, Chairman. I appreciate the
hearing and I look forward to working with you and Senator Burr
on the reauthorization.
Senator Casey. Thanks, Senator Whitehouse.
I know we are running low, we are pretty much at the end of
our time. But I wanted to maybe ask two more questions and then
we will say something about leaving the record open.
Ms. Arthur, I wanted to ask you about this issue that I
know you have had a concern about. The particular challenge you
face with regard to developing countermeasures for at-risk
populations. We have heard a good bit today about children. Can
you highlight those, from the perspective of whether they are
just bureaucratic or other challenges or whether they are
scientific hurdles. But you are looking at it from the private
sector, from the nongovernmental sector, we will call it. Can
you outline some of those challenges?
Ms. Arthur. Absolutely. Thank you for the question.
Actually I think that the--looking at special populations
adds an extra dimension of complexity. So, as we were talking
about before, a lot of the products, the countermeasures need
to be researched, generally using the animal model guidance and
the animal model rule, because you really can't do the key
testing on efficacy in humans, you have to do it in these
animals. The problem is, it is not always clear which animal is
the right model to use. And add to that, not necessarily surety
about which animal is the right animal to use to exemplify
children.
So you add a layer of scientific complexity that needs to
be solved in concert with the FDA. So a lot of the companies
that are trying to not just license a countermeasure for use in
healthy adults, but in all of the population, need to really be
able to work in concert with the FDA on how to answer the key
question. If the goal is to have a product that you can use
after exposure and you want to be able to use across all
populations, you need to really think through which models to
use and what questions you are going to answer and what
scientific rigor you are going to have to apply to that. That
is really one of the key problems that we would like to have
solved through the FDA review.
So, the reason why we are supporting the FDA process so
strongly is precisely because they really want to put resources
toward those key scientific questions that all countermeasure
sponsors have.
Senator Casey. Thank you very much.
I just have one more question. Commissioner Cooper, are
there, and I am assuming there are, particular challenges in
rural communities? Can you outline some of those, because often
when we turn on the news and we see some of these horrific
images, they invariably seem to be in smaller communities and
often communities that are, at least by demographics, rural.
Any insights or--it may be better to say any concerns that you
have or any suggestions you have as to how we can better
prepare for those communities?
Ms. Cooper. Certainly Tennessee is a very rural State. We
are about 42,000 square miles, touching about eight other
States. And we have worked in a very strategic fashion to put
counties into regions across the State, because similar rural
counties had similar issues, whether it is lack of resources.
You think about community hospitals, or you may have a single
healthcare provider, if you have one in that community. You
think about the emergency medical system, it is more
sophisticated in urban areas than it is in a rural community.
All of these are key players and key partners in the public
health response.
Even when I talked about earlier, the pharmacies, when you
think back to H1N1 we had a very aggressive program with
Tamiflu, making it available to all persons across the State.
But we had two counties in our State that don't have a pharmacy
in it, so you had to come up with a redundant system to address
those needs.
I think our regional strategy has worked very well. I think
there are some lessons to be learned from that. But again, it
is really about the capacity of not just the public health but
the medical system in place to respond to these emerging
disasters.
Senator Casey. I know we are wrapping up. I just wanted to
make sure that I put on the record that we will keep the record
open for 10 days for members of the committee to submit
statements for the record and for testimony.
And unless there is something any of you would want to add,
we will conclude. But certainly the record will be open, not
only for more questions that will be presented, due to answer
in writing, but of course if you feel the need to supplement
your testimony or provide other information that is certainly
an option available to you.
Thanks for your help and thanks for enlightening us as we
begin this process of reauthorization.
We are adjourned. Thank you.
[Additional material follows.]
ADDITIONAL MATERIAL
Prepared Statement of Senator Mikulski
Chairman Harkin, thank you for organizing today's hearing
on public health, medical, and bioterrorism preparedness. Also,
I appreciate Senator Enzi and Senator Burr's long-standing
efforts to improve our Nation's ability to respond to public
health emergencies.
Terrorism is a danger to us on many fronts. We must prepare
ourselves to respond to all hazards that impact our Nation's
security. Every day, Americans are faced with natural disasters
in our communities--floods, hurricanes, earthquakes, and food
safety outbreaks. These incidences challenge our Federal
ability to assist those in harm's way and the States'
capabilities to respond to local needs.
Today as we scrutinize every dollar spent, this hearing
will be important in showing how our past investments have made
us more prepared for the unexpected, and how future investments
and resources can be utilized more efficiently.
I also hope this hearing will demonstrate how Congress can
come together in a bipartisan fashion, and bridge the all-too-
common partisan divisions, when it comes to protecting our
citizens.
As I have said before, the key question we must address
today is readiness. Are we ready to respond to all hazards? We
are better prepared than we ever have been before, yet the
distressing answer to the question is No.
If a major catastrophic health event occurs in the United
States--such as the earthquake and tsunami in Japan, or another
Hurricane Katrina, or a severe pandemic, or bioterrorism
attack--our infrastructure for the response will be stretched
to the breaking point. And our Nation's most vulnerable
populations--children, the elderly, and Americans with
disabilities--will be the ones most at risk.
Fortunately we do have efforts underway that must continue.
We have newly developed countermeasures that we did not have a
decade ago. The Strategic National Stockpile contains medicines
to protect Americans against smallpox, anthrax, and nerve
agents.
Maryland has been a leader in our national and public
health security. Fort Detrick in Maryland is on the frontlines
of bioweapons research to develop our best defense against
these weapons. I am proud of these Federal employees. Also,
Maryland's biopharmaceutical manufacturers are working closely
with Dr. Lurie and the Biomedical Advanced Research and
Development Authority to develop novel countermeasures for our
Nation's Strategic National Stockpile.
Marylanders at Emergent Biosolutions, PharmAthene, Human
Genome Sciences, Cangene, and Medimmune are developing the next
generation anthrax vaccine; improving our manufacturing
platforms for influenza vaccines; creating better medications
to treat people exposed to nerve agents; and working to conquer
infectious diseases like tuberculosis and typhoid.
I am also proud of the work we have done in Congress to
assist our biotech companies, our pharmaceutical companies, and
our local, State, and Federal agencies in preparing for some of
the most common threats we face.
I remember last time I worked with Senator Burr on this
legislation, and I look forward to improving upon the law in a
bipartisan fashion in order to deliver the most protection for
our country. I look forward to hearing from all of our
witnesses today about the accomplishments and challenges we
face with developing medical countermeasures and sustaining our
public health infrastructure so that health agencies are able
to respond to all hazards. We must ensure our Nation is secure
when national disasters strike and terrorists try to attack us.
These are national problems that require national solutions
and national leadership from the Federal Government. We must
not wait for the disaster to occur. We must have a plan of
defense and have a plan of offense.
I look forward to working with my colleagues to make sure
we are ready to combat tomorrow's threats!
Prepared Statement of Senator Hagan
I would like to thank Chairman Harkin for holding this
hearing today. I would also like to thank the Assistant
Secretary for Preparedness and Response at HHS, Dr. Lurie, and
all the witnesses for coming before the committee to discuss
strengthening our Nation's medical and public health
preparedness and response.
Our experiences during the September 11 terrorist attacks,
the 2001 anthrax attacks, Hurricane Katrina, the 2009 H1N1
influenza pandemic, and the 2010 Deepwater Horizon oil
disaster, clearly show how important it is for our Nation to
continually improve our public health emergency preparedness
and response activities.
Earlier this month, the long hunt ended for the terrorist
leader, Osama bin Laden. I am extremely proud of the U.S.
Special Forces and our intelligence community that finally
brought down this mass murderer. I am pleased that justice was
served and I hope this event can bring some peace to our 9/11
families and the country.
However, the terrorist threat to our Nation remains. The
Commission on the Prevention of Weapons of Mass Destruction
Proliferation and Terrorism has repeatedly warned of the near-
term threat of a biological attack and the need to enhance our
capabilities to rapidly respond to such threats and potential
attacks. Just a few months ago, the Directors of the Central
Intelligence Agency and the National Counterterrorism Center
testified to Congress that Al Qaeda is still intent on
developing chemical, biological, radiological, and nuclear
attack capabilities. Our Nation must be prepared for any such
attacks and we must consider our public health preparedness as
a national security objective.
The Pandemic and All-Hazards Preparedness Act of 2006
(PAHPA) reauthorization is timely and urgent. In addition to
making preparedness a national security priority, we need to
focus on: interagency coordination; addressing real-time
detection and biosurveillance capabilities; ensuring that
hospitals and clinicians are equipped in the event of a
pandemic; ensuring that special populations, like children and
the elderly, have access to appropriate countermeasures; and
finally, establishing a prospective multi-year plan for
preparedness including research, development, and stockpiling.
I look forward to hearing from our witnesses today as we
discuss the reauthorization of this important legislation.
Prepared Statement of Governor Lowell P. Weicker, President of the
Board of Directors, Trust for America's Health
My name is Lowell P. Weicker, and I am president of the board of
directors of Trust for America's Health (TFAH), a nonprofit,
nonpartisan organization dedicated to saving lives by protecting the
health of every community and working to make disease prevention a
National priority. I am grateful for the opportunity to submit
testimony to the committee on reauthorization of a groundbreaking piece
of legislation, the Pandemic and All-Hazards Preparedness Act (PAHPA).
PAHPA represented a major step in acknowledging and developing the
role of America's public health system in preparing for and responding
to major emergencies, whether natural or man-made. The reauthorization
of PAHPA is an opportunity to build more prepared and resilient
communities, able to weather a storm, contain its impact, and return to
normal as quickly as possible. I applaud the committee for
demonstrating its commitment to better preparing our Nation for
disasters.
I have two major points to make in my testimony today:
First, our Nation faces continuing natural and man-made threats
that require an ongoing commitment to public health preparedness. This
is a national security threat--as direct as any we face abroad. The
death of Osama Bin-Laden does not erase that threat; there are still
very creative terrorists out there and our guard cannot be let down.
Second, we must fund public health preparedness with the same level
of commitment as we have made to other national security priorities.
This means: (a) we must assure reliable, predictable funding for public
health preparedness, in contrast to the 27 percent decline faced over
the last several years; (b) we must assure that State and local health
departments are given flexibility to use all employees supported with
Federal funds during an emergency and not be hamstrung by categorical
restrictions; (c) and we must fully embrace the spirit of ``all
hazards'' in PAHPA by recognizing that almost every public health
program contributes to preparedness. As our health care system
modernizes--especially with regard to health information technology--we
must be sure public health programs, such as biosurveillance, adapt as
well, including by leveraging existing resources in more creative ways.
The public health system has always been integral in our response
to natural disasters and terrorist attacks. Public health was on the
frontlines of the response to 9-11 and to the anthrax attacks. It is as
fundamental to the Nation's security as our military and as fundamental
to local protection as fire and rescue. Passage of PAHPA codified and
expanded the Federal Government's support for this role. As a result of
this legislation, and the investments that followed, our Nation is more
prepared than ever. We saw this in the response to the H1N1 outbreak in
2009, when nearly every State and jurisdiction implemented its pandemic
influenza plan in response to the H1N1 outbreak, with activities
including disease surveillance, ongoing communication updates, carrying
out vaccination campaigns and the coordination of response efforts with
partners.\1\
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\1\ Centers for Disease Control and Prevention, Public Health
Preparedness: Strengthening the Nation's Emergency Response State by
State, September 2010. Available from: http://emergency.cdc.gov/
publications/2010phprep/pdf/complete_PHPREP_report.pdf.
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In TFAH's 2010 report, Ready or Not?, we found that States had made
enormous progress since the events of 2001 in planning for and
responding to disasters. The Public Health Emergency Preparedness
(PHEP) cooperative agreement and Hospital Preparedness Program (HPP),
Federal, State, and local attention to the role of public health in
emergency preparedness, and real-world experiences such as the H1N1
outbreak have helped us bring preparedness to the next level. However,
the report also found that the economic crisis is putting almost a
decade of gains at serious risk. While emergency H1N1 and stimulus
funds may have helped States weather the storm of the pandemic, we
cannot continue to fund preparedness on a disaster-by-disaster basis.
Our report found that 33 States and DC cut public health funding from
fiscal years 2008-9 to 2009-10, with 18 of these States cutting funding
for the second year in a row. In addition, Federal support for public
health preparedness was cut by 27 percent between fiscal year 2005 and
fiscal year 2010 (adjusted for inflation). We expect to see major cuts
to Federal public health preparedness programs in both fiscal year 2011
and 2012. These inconsistencies represent the greatest threats to our
ability to respond to a public health catastrophe on the level of the
Japan earthquake and tsunami.
We believe a modernized, prepared public health system must address
several remaining gaps:
A Workforce Gap: The National Association of County and
City Health Officials reports that we have lost roughly 19 percent of
the local health department workforce since 2008. This loss of
experience has a staggering impact on preparedness, as workers cannot
simply be hired and trained once a disaster strikes.
A Surge Capacity Gap: Surge capacity, the ability of the
medical system to care for a massive influx of patients, requires
ongoing planning, funding, and coordination across healthcare, public
health, first responder, and private sectors.
A Surveillance Gap: The Nation still lacks an integrated,
national approach to biosurveillance, which could significantly improve
response capabilities for emergencies.
Gaps in Medical Countermeasure Development: The research
and development of vaccines, antivirals, diagnostics, and other
countermeasures is years ahead of where we were during the 2001 anthrax
outbreak; yet our ability to spur innovation in these limited-use
technologies has been hampered by a lack of stable funding and some
breakdowns in program administration.
PAHPA reauthorization represents an opportunity to fill some of
these critical gaps. As you begin consideration of amending the law,
TFAH would like to offer the following recommendations:
1. Strengthen Public Health Preparedness Infrastructure: The
economic recession has led to cuts in public health staffing and eroded
the basic capabilities of State and local health departments.
Strengthening the public health preparedness workforce and
infrastructure is critical to ensuring the health protection of our
Nation. It also requires adequate funding and human resources to
recruit and train personnel, stockpile life saving countermeasures,
develop and exercise plans, and identify and engage partners to support
the public health mission. The resources required to truly modernize
public health systems must be made available to bring public health
into the 21st century and improve preparedness.
The PHEP cooperative agreements and HPP are two key grant programs
that support the development and sustainability of State and local
public health preparedness infrastructure. Since their inception, these
programs have increased the capacity of State and local health
departments and health systems to prepare for and respond to a
disaster.\2\ \3\ Our 2010 report found that these funding streams have
contributed to major progress in workforce training, epidemiology and
laboratory capacity, surveillance, and planning and exercising at the
State and local level.
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\2\ Centers for Disease Control and Prevention, Public Health
Preparedness: Strengthening the Nation's Emergency Response State by
State, Sept 2010. http://emergency.cdc.gov/publications/2010phprep/
index.asp.
\3\ Center for Biosecurity, Hospitals Rising to the Challenge: HPP
Evaluation Report, March 2009. http://www.upmc-biosecurity.org/website/
resources/publications/2009/2009-04-16-hpp
report.html.
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During the 2009-10 H1N1 influenza outbreak, State and local health
departments were on the front lines responding to the pandemic, though
many were limited in their efforts as a result of Federal and State
budget cuts, particularly those that have occurred over the past 5
years. These budget crises demonstrated, among other things, the need
to build in mechanisms to allow more flexibility in how staff, funded
by Federal grant programs, are used during emergencies. In the H1N1
influenza response, the ability to re-assign staff from other federally
funded projects in health departments could have improved the financial
and human resource efficiencies of that agency's response to the
influenza pandemic, especially during the earlier response phases when
additional funding was not yet available and jurisdictions needed to
mobilize ``all hands on deck.'' To address these concerns, we recommend
language that would:
Establish multi-year grant cycles with greater flexibility
in States' retention and use of carry forward and unexpended funds;
Create a mechanism to fast track the awarding and
programming of emergency supplemental funds into existing grant
mechanisms without additional match or maintenance of funding
requirements; and
Grant authority to the Secretary to allow States to also
use personnel that are part of other Federal programs in response to a
public health emergency (e.g. an ``all hands on deck'' scenario).
We understand that HHS and the Department of Homeland
Security (DHS) have begun working to align grant programs that aim to
build our Nation's emergency preparedness capacity, including PHEP,
HPP, and FEMA grants. Currently the PHEP and HPP grants, both of which
are often distributed through public health departments, have separate
application and reporting requirements, overarching goals, and in some
cases conflicting performance metrics. We believe the alignment process
should include coordinating grant priorities and goals, grant cycles,
and streamlining application and reporting mechanisms to achieve
maximum efficiency. I urge you to use PAHPA to ensure oversight and
proper implementation of this alignment process.
2. Modernize Biosurveillance: Situational awareness--knowing what
the threats are, and knowing what our capacity to respond is, at any
given moment--is critical to responding to any emergency and we need to
make sure we are building capacity using 21st century technology and
approaches. We have built our disease surveillance system one disease
at a time and one crisis at a time, rather than as a unified,
interoperable unit. Rather than continuing these silos, we have the
opportunity to think across diseases (infectious and chronic) and
emergency situations, because health information technology is
advancing at a rapid pace and the health care system is becoming
electronic.
It is time for public health to do the same. Imagine a system where
a provider inputs data into an electronic health record, the health
department is rapidly informed of a cluster of unusual symptoms
(indicating an outbreak), and the health department then communicates
with the provider and responds quickly with the appropriate
intervention. Right now, the ability of health departments to receive
and analyze electronic data varies widely from jurisdiction to
jurisdiction. Because the Federal Government is in the process of
catalyzing adoption of electronic health records, now is the time to
think about how to incorporate public health into the system. PAHPA can
help fill this gap:
PAHPA should call for a new national strategy, led by HHS
and CDC, that would examine means to achieve interoperability and
transparency among various surveillance systems.\4\ The United States
lacks an integrated, national approach to biosurveillance, and there
are major variations in how quickly States collect and report data
which hamper bioterrorism and disease outbreak response capabilities.
The lack of an overarching Federal biosurveillance strategy has led to
fragmentation, multiple separate surveillance systems, and barriers to
relevant agencies prioritizing and synthesizing data.\5\ \6\ And
according to a December 2010 GAO report, HHS had not provided a
strategic plan for electronic situational awareness, as required by
PAHPA.\7\
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\4\ Nuzzo, Jennifer, Center for Biosecurity of UPMC. ``Developing a
National Biosurveillance Program,'' Biosecurity and Bioterrorism.
Volume 7, Number 1, 2009. http://www.upmc-biosecurity.org/website/
resources/publications/2009/biomemo/2009-03-27-
develop_natl_biosurveill-
ance.html.
\5\ Nuzzo, 2009.
\6\ Vinter, S. et al., Trust for America's Health, Ready or Not?
2009: Protecting the Public's Health from Diseases, Disasters, and
Bioterrorism. December, 2009. http://healthyamericans
.org/reports/bioterror09/pdf/TFAHReadyorNot200906.pdf.
\7\ U.S. Government Accountability Office, Public Health
Information Technology: Additional Strategic Planning Needed to Guide
HHS's Efforts to Establish Electronic Situational Awareness
Capabilities. http://www.gao.gov/products/GAO-11-99.
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The national strategy should also call for leveraging of
new epidemiological data that may become available as a result of the
development of health information technology (IT) and electronic health
records (EHRs). There is no overarching coordination between public
health surveillance efforts at HHS and the work of the Office of the
National Coordinator for Health Information Technology (ONC). The ONC
should work closely with a designated person at CDC and with State/
local/tribal/territorial partners, with PAHPA mandating this
synchronization and collaboration. For example, as ONC develops new
standards for meaningful use of health IT, it should incorporate the
preparedness and biosurveillance implications of such technologies.
Interoperability between public health and EHRs could not only help
with early detection of an emerging disease outbreak or bioterror
attack, but could also help with identification of targeted populations
or geographic regions to receive medical countermeasures and tracking
the post-dispensing impact of medical interventions.
3. Improve Vaccine and Pharmaceutical Research, Development, and
Manufacturing: The United States is falling behind in its research and
development of medical countermeasures to fight public health threats.
As the Nation revamps its approach to research and development of
vaccines, medicines, diagnostics and equipment to respond to emerging
public health threats, policymakers must ensure public health is
involved throughout the process, from initial investment through
distribution and dispensing. PAHPA can advance the Nation's MCM
enterprise through the following activities:
Congress should consider authorizing President's requests
for MCM advancement: building an MCM Strategic Investor to leverage
private capital for promising technologies; using unspent H1N1 money to
establish Centers for Innovation in Advanced Development and
Manufacturing; and developing end-to-end leadership to see products
through from initial research through dispensing. However, bill
language should request additional detail from HHS on how these
programs would be implemented, including multiyear professional
judgment budgets for implementation of the PHEMCE strategy.
Report language in PAHPA should urge: (1) increased
coordination between FDA, BARDA, NIH, and CDC from initial investment
through dispensing; (2) improved transparency of the development
process, including regulatory pathways by FDA and contracting process
with BARDA and Bioshield; and (3) MCM strategy should be end-to-end--
not just focused on initial investments, but on advance development,
procurement, distribution, and surveillance.
Improving SNS Management: There should be a plan for
stocking the Strategic National Stockpile (SNS) and for ongoing
replacement of expiring product, especially vaccines,\8\ pediatric
doses of antimicrobials, antivirals and other products, and restocking
materiel used as a result of the H1N1 outbreak. This plan should also
include a professional judgment budget for replacing product expiring
over the next several years. The legislation should also call for
increased coordination between CDC and BARDA on SNS procurement and
management.
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\8\ Testimony of Robert Kadlec Before House Homeland Security
Subcommittee on Emerging Threats, Cybersecurity, and Science and
Technology. June 15, 2010. http://hsc.house.gov/SiteDocuments/
20100615131640-79968.pdf.
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Authorize extension of the Shelf-Life Extension Program
(SLEP) to State stockpiles of medical materiel. Currently, only
federally held stockpiles are eligible for the SLEP, which can be a
cost-effective way to maintain State and local supplies.
4. Enhance Surge Capacity: In the event of a major disease outbreak
or attack, the public health and health care systems would be severely
overstretched. Policymakers must address the ability of the health care
system to quickly expand beyond normal services during a major
emergency. Investments in research and development, stockpiling, and
practice in drills and tabletop exercises will aid in the timely
distribution of antivirals and other equipment during an outbreak.
PAHPA should facilitate health care preparedness by:
Encouraging enhancements in the Hospital Preparedness
Program (HPP). The HPP, administered by the Assistant Secretary for
Preparedness and Response (ASPR), aims to prepare the Nation's health
system for the medical and logistical impacts of a disaster. Rather
than continuing to fund individual hospitals for preparing for a
crisis, HPP has played a role in spurring creation of regional
healthcare coalitions, alliances between hospitals, public health, and
emergency management.\9\ These coalitions allow for a shared burden and
reduce surge to any single facility. However, in many regions, this is
still a nascent process.\10\ Building and developing these coalitions
should be an explicit goal of HPP, including expanding coalitions to
every city and linking them into a national system.
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\9\ Toner, Eric, et al., Center for Biosecurity of UPMC. Hospitals
Rising to the Challenge: The First Five Years of the U.S. Hospital
Preparedness Program and Priorities Going Forward, March, 2009. http://
www.upmc-biosecurity.org/website/resources/publications/2009/pdf/2009-
04-16-hppreport.pdf.
\10\ Toner, Eric. Expert perspective in Ready or Not? 2009. http://
healthyamericans.org/assets/files/TFAH2010ReadyorNot%20FINAL.pdf.
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Clarifying crisis standards of care. The Federal
Government should provide a national framework to guide States and
local entities in developing crisis standards for use during a mass
casualty event. Leaving this process up to the States has not led to
enough progress in developing a better understanding of the kind of
care that would be available in a disaster.
Clarifying Federal volunteer liability laws to implement
one, blanket liability that applies to all volunteer health
professionals and entities volunteering under a nationally declared
public health emergency or disaster. HHS has acknowledged that a
patchwork of Federal liability laws is confusing and frustrating to
providers.\11\ There should also be Federal Tort Claims Act protection
for Medical Reserve Corps volunteers year-round, as these personnel
participate in public health drills and training during times of non-
disaster.
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\11\ DHHS, Office of the General Counsel, ``Public Health
Emergencies and Federal Health Law.'' Presentation at 2010 Public
Health Preparedness Summit, February 2010. http://www.phprep.org/2010/
Agenda/upload/Interactive-145.pdf.
Thank you for this opportunity to weigh in as the committee
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considers reauthorization of PAHPA. I look forward to your questions.
[Whereupon, at 4:26 a.m., the hearing was adjourned.]